Quality Assurance Specifications Research Articles

Stability of Medicines Transported by Cargo Drones: Investigating the Effects of Vibration from Multi-Stage Flight

The timely distribution of medicines to patients is an essential part of the patient care plan, and maximising efficiency in the logistics systems behind these movements is vital to minimise cost. Before drones can be used for moving medical cargo, medical regulatory authorities require assurance that the transported products will not be adversely affected by in-flight conditions unique to each drone. This study set out to (i) quantify the vibration profile by phases of flight, (ii) determine to what extent there were significant differences in the observed vibration between the phases, and (iii) assess the quality of flown monoclonal antibody (mAb) infusions used in the treatment of cancer. Vibrations emanating from the drone and transmitted through standard medical packaging were monitored with the storage specifications for mean kinematic temperature (2–8 °C) being met. Vibration levels were recorded between 1.5 and 3 g, with the dominant octave band being 250 Hz. After 60 flights, the quality attributes of flown infusions regarding size integrity were found to be no different from those of the control infusions. For example, the particle size had a variation of less than 1 nm; one peak for Trastuzumab was 14.6 ± 0.07 nm, and Rituximab was 13.3 ± 0.90 nm. The aggregation (%) and fragmentation (%) remained at 0.18 ± 0.01% and 0.11 ± 0.02% for Trastuzumab, 0.11 ± 0.01% and 2.82 ± 0.15% for Rituximab. The results indicated that in the case of mAbs, the quality assurance specifications were met and that drone vibration did not adversely affect the quality of drone-flown medicines.

Case Studies of Asphalt Pavement Quality Assurance Specifications, Performance-Related Specifications, and Performance-Based Specifications

Quality assurance (QA) specifications for asphalt pavement construction measure quality characteristics to adjust payments. The measured quality characteristics are assumed to empirically relate to performance. The validity of this assumption, however, has been questioned in recent years; thus, there has been increased interest in finding ways to more directly evaluate the performance of the as-constructed materials. One proposed method to meet this need involves using the Asphalt Mixture Performance Tester (AMPT) and its associated test methods, which measure fundamental material properties that are then used to calculate the fatigue cracking performance index, Sapp, and a rutting strain index (RSI). These indices can be used in performance-related specification (PRS) or performance-based specification (PBS) frameworks to determine the pay adjustments during the construction of asphalt pavement. While PBS requires measured indices, PRS uses index-volumetrics relationships (IVRs) to predict Sapp and RSI based on conventional acceptance quality. Payment can then be based on a percent within limits (PWL) approach. This paper demonstrates how pay adjustments can be made for a paving project in Indiana following three different QA specification frameworks: the current QA specifications framework in the Indiana Department of Transportation, a PRS framework using IVRs, and a PBS framework that employs measured Sapp and RSI. For each framework, the main elements of the specification were identified and determined. The specification limits for Sapp and RSI and weight factors in composite pay factor equations were determined such that the resulting pay factors are comparable to pay factors obtained from the current QA practices.

Compaction Quality Assurance Specifications of Unbound Materials

Compaction quality control/assurance of unbound geomaterials is one of the crucial components in pavement and embankment construction to ensure their performance, stability, and sustainability. Conventional density-based methods such as nuclear density gauge to determine the compaction quality have been widely used due to the straightforward relationship between the readings and targeted material property. Recent modifications in construction standards and the introduction of the Mechanistic-Empirical Pavement Design Guide have inspired a growing interest in developing and implementing strength/stiffness-based compaction control quality assurance (QA) specifications. Numerous studies have been dedicated to investigating the efficiency and effectiveness of the stiffness-based compaction QA tools. This paper presents a comprehensive review of the recent compaction QA relevant literature and surveys. Findings of different approaches for studying QA devices, and the main results of the existing models, experiments, and engineering practices were summarized. Several in situ spot QA technologies, including the latest compaction QA technologies [e.g., the lightweight deflectometer (LWD)], were highlighted, and their efficiency and effectiveness were compared. The review also summarized the intercorrelations between different devices, the correlations between in situ QA device readings and mechanical properties of unbound material, findings of the numerical simulations, and case studies and current practices using different QA tools. The recommendations for future research needs and practical implementations were identified and discussed.

Variability, Sensitivity, and Econometric Analyses of Field Density in Pay for Performance Data for Hot-Mix Asphalt in Illinois

Pay for Performance (PFP) is a statistical-based quality assurance specification used to evaluate asphalt concrete construction for projects having mix quantities greater than 7,260 t (8,000 US tons). The contractor pay is adjusted based on mix field density, air voids, and voids in mineral aggregate. In this study, data were analyzed from the 2015 to 2017 highway construction seasons in Illinois to determine variability trends. Density was the major factor driving contractor pay disincentives in PFP, followed by air voids. To identify the impact of construction field density consistency on the final pay factor, a sensitivity analysis was performed to determine the changes in the contractor pay with respect to variability, which is measured by standard deviation. In addition, an econometric analysis based on sensitivity analysis using linear regression was conducted. The results showed that a 1% reduction in density standard deviation led to a 0.066 increase in density pay factor. Based on the 79 projects analyzed, if the density standard deviation had been reduced from 1.67 to 1.0, the average increase in pay per project would be $38,000.

Using three external quality assurance schemes to achieve equivalent international normalized ratio results in primary and secondary healthcare

Accurate prothrombin time international normalized ratio (INR) results are essential for safe anticoagulation treatment. Patients are treated both in primary and secondary healthcare, therefore equivalence of INR results from point-of-care (POC) and hospital measurement procedures (MPs) are important. It is not possible to evaluate this equivalence in traditional external quality assessment (EQA). The aim of this paper is to describe a special quality assurance system consisting of three different EQA schemes to monitor the harmonization of INR results in Norway. The EQA scheme for hospital laboratories uses commutable control materials and evaluates participant performance and the equivalence of hospital MPs. The EQA scheme for primary healthcare laboratories uses non-commutable control materials and evaluates participant performance. A third EQA scheme for selected primary healthcare laboratories uses native patient split samples and evaluates the equivalence between POC and hospital MPs. The relationship between the three EQA schemes ispresented. The split sample EQA scheme provides a link between the hospital scheme and the scheme for primary healthcare. Results from 2017 to 2022 are presented for all three schemes. When aberrant EQA results occur Noklus takes actions to be able to have a sustainable equivalence between INR results. All three EQA schemes are important for monitoring the harmonization of INR results in Norway. This quality assurance system, including help and guidance of the participants, will reduce the risk of harm to patients due to non-equivalence of results from different MPs.

Demonstration Project for Ground Tire Rubber and Post-Consumer Recycled Plastic-Modified Asphalt Mixtures

Research has demonstrated that asphalt pavements can be a strategic destination for some of the major streams of waste materials around the globe, such as scrap tires and plastics. Ground tire rubber (GTR) from scrap tires has been used in asphalt pavements since the 1960s but has yet to approach its full potential in relation to market adoption. The heightened restrictions imposed by China in relation to waste stream contamination in 2018 have catalyzed research on incorporating post-consumer recycled (PCR) plastics into asphalt pavements. A field demonstration project was carried out in Columbia, MO to evaluate modern recycled plastic and GTR additives in an asphalt pavement overlay. The demonstration focused on dry-process modification, which requires minimal alterations to an existing asphalt plant and allows a higher amount of recyclates to be utilized. The project was also designed to assist in the Missouri Department of Transportation’s early roll-out of balanced mix design asphalt design and quality assurance specifications. The results of the study indicated the viability of dry-process GTR and PCR plastic additives used with neat (unmodified) asphalt binder as an alternative to binders modified with virgin polymers, chemical treatments, or both, in a wet process. The results of the study also suggest the viability of hybrid wet polymer-modified binder with dry-process PCR plastic as a greener alternative to binders modified with virgin polymers, chemical treatments, or both. Future studies will be needed to examine additional PCR plastic streams, especially mixed polymer streams.

Automated radiosynthesis of [11 C]MTP38-a phosphodiesterase 7 imaging tracer-using [11 C]hydrogen cyanide for clinical applications.

We have developed 8-amino-3-(2S,5R-dimethyl-1-piperidyl)-[1,2,4]triazolo[4,3-a]pyrazine-5-[11 C]carbonitrile ([11 C]MTP38) as a positron emission tomography (PET) tracer for the imaging of phosphodiesterase 7. For the fully automated production of [11 C]MTP38 routinely and efficiently for clinical applications, we determined the radiosynthesis procedure of [11 C]MTP38 using [11 C]hydrogen cyanide ([11 C]HCN) as a PET radiopharmaceutical. Radiosynthesis of [11 C]MTP38 was performed using an automated 11 C-labeling synthesizer developed in-house within 40 min after the end of irradiation. [11 C]MTP38 was obtained with a relatively high radiochemical yield (33 ± 5.5% based on [11 C]CO2 at the end of irradiation, decay-corrected, n = 15), radiochemical purity (>97%, n = 15), and molar activity (47 ± 12 GBq/μmol at the end of synthesis, n = 15). All the results of the quality control (QC) testing for the [11 C]MTP38 injection complied with our in-house QC and quality assurance specifications. We successfully automated the radiosynthesis of [11 C]MTP38 for clinical applications using an 11 C-labeling synthesizer and sterile isolator. Taken together, this protocol provides a new radiopharmaceutical [11 C]MTP38 suitable for clinical applications.

Validation of monaco TPS for an ELEKTA synergy MLCi2: Using gamma index for eElekta full package beams

Intensity modulated radiotherapy (IMRT) is an advance technique of radiotherapy. The clinical implementation of IMRT requires special quality assurance (QA) procedures for Multileaf collimator (MLC).For the linear accelerators (Linac) from the manufacturer Elekta, the relationship between the MLC and delivered dose from the Linac was controlled by test beams called Full package QA, provided by the manufacturer Elekta. This package was carried out to refine the modeling of MLC in order to establish a QA protocol.In order to study how the modifications of the parameters of the treatment planning system (TPS) affect the calculations of the delivered dose distributions, we introduced different plans proposed by the Full Package QA in the TPS and we compared their dose distribution to the dose distribution measured obtained from Elekta Synergy MLCi2 in MyQA Patient (IBA, Germany).All the Full Package QA beams, IMRT / VMAT treatment plans for different locations were calculated in Monaco 5.11 TPS using 3 mm grid and 0.5% per control point statistical uncertainty, and verified on the machine using the gamma index analysis tool.A majority of the beams showed a gamma pass rate greater than 95% based on 3% DD and 3 mm DTA. Our results show the importance of gamma analysis method to predict the quality of dose calculation, and we demonstrate that the Full package QA can be integrated into an IMRT quality assurance programme.

Radiosynthesis and quality control testing of the tau imaging positron emission tomography tracer [18 F]PM-PBB3 for clinical applications.

Recently, we produced 11 C-labeled 2-((1E,3E)-4-(6-(methylamino)pyridin-3-yl)buta-1,3-dienyl)benzo[d]thiazol-6-ol ([11 C]PBB3) as a clinically useful positron emission tomography (PET) tracer for in vivo imaging of tau pathologies in the human brain. To overcome the limitations (i.e., rapid in vivo metabolism and short half-life) of [11 C]PBB3, we further synthesized 18 F-labeled 1-fluoro-3-((2-((1E,3E)-4-(6-(methylamino)pyridine-3-yl)buta-1,3-dien-1-yl)benzo[d]thiazol-6-yl)oxy)propan-2-ol ([18 F]PM-PBB3). [18 F]PM-PBB3 is also a useful tau PET tracer for imaging tau pathologies. In this study, we developed a routine radiosynthesis and quality control testing of [18 F]PM-PBB3 for clinical applications. [18 F]PM-PBB3 was synthesized by direct 18 F-fluorination of the tosylated derivative, followed by removal of the protecting group. [18 F]PM-PBB3 was obtained with sufficient radioactivity (25 ± 6.0% of the nondecay-corrected radiochemical yield at the end of synthesis, EOS), radiochemical purity (98 ± 0.6%), and molar activity (350 ± 94 GBq/μmol at EOS; n = 53). Moreover, [18 F]PM-PBB3 consistently retained >95% of radiochemical purity for 60 min without undergoing photoisomerization using a new UV-cutoff light (yellow light) fixed in the hot cell to monitor the synthesis. All the results of the quality control testing for the [18 F]PM-PBB3 injection complied with our in-house quality control and quality assurance specifications. We have accomplished >200 production runs of [18 F]PM-PBB3 in our facility for various research purposes.

The effect voltage Device of x-ray on radiation doses and image quality

The X-ray tube generates diagnostic X-rays, and these rays can penetrate the human body and to different dimensions depending on the energy of the rays. These rays meet absorption and scattering inside the body, and whatever comes out of them is used for radiological examination purposes. Radiation exposure accompanies some of the potential risks, so it requires knowing the amount of radiation dose for the total exposed (man. Sv), as well as the equivalent effective dose for the organ or tissue in the body, and multiplied by the value determined by the risk factor, thus determining the amount of radiation risk or the rate of infection Radiative damage. The surface entry dose values measured by the German-born Dosimax mobile device are closer to the reference values, because the sensitive size of this meter is a material equivalent to living tissue, which is exposed to X-rays, so the reading value of the dose in the air is not the same as in the case of the ionization chamber (Unfors) is Swedish in origin, but rather the dose of live tissue which is an approach to the dose of patients. The amount of fluctuation in the measuring voltages of the device (C) is 11.3% which is higher than the specified values, and also the standard deviation in the measurement is more than 5%, that is, the device does not meet the quality assurance specifications (QA), while the two devices (F, E) are The volatility value is 3.89% and 4.6%, respectively, which is less than the limits set for this fluctuation of 10%, and the standard deviation values are less than 5%.

IMPLEMENTASI PENJAMINAN MUTU MADRASAH

Quality control in the management of education is faced with constraints of limited educational resources. Therefore we need an effort to control quality in the form of guarantees, so that all aspects related to education services provided are in accordance with or exceeding national education standards. This paper aims to describe the implementation of education quality assurance in Madrasah Aliyah An-Najiyah Bandung, including; implementation of madrasah quality assurance, quality implementation obstacles, and solutions in overcoming obstacles to implementing quality assurance in Madrasah aliyah An-Najiyah Bandung. This research uses a qualitative approach through descriptive methods. The data collection techniques using in-depth interviews, observation, and literature study. The results showed that; first, In terms of quality assurance in terms of the eight national education standards in Madrasah Aliyah An-Najiyah, Bandung, it is at a good standard level and even exceeds the minimum service standard so that it becomes a distinct advantage for this madrasa. High competitive power makes the process of implementing quality assurance more stringent. Second, the internal obstacle that arises is the absence of a special quality assurance institution internal to the institution that controls all aspects of quality assurance. Third, the solution to the obstacles that arise will be minimized if institutionally already built.

Dosimetric and preparation procedures for irradiating biological models with pulsed electron beam at ultra-high dose-rate

PurposePreclinical studies using a new treatment modality called FLASH Radiotherapy (FLASH-RT) need a two-phase procedure to ensure minimal uncertainties in the delivered dose. The first phase requires a new investigation of the reference dosimetry lying outside the conventional metrology framework from national metrology institutes but necessary to obtain traceability, repeatability, and stability of irradiations. The second consists of performing special quality assurance procedure prior to irradiation. Materials and MethodsThe Oriatron eRT6 (PMB-Alcen, France) is an experimental high dose-per-pulse linear accelerator, delivering a 6 MeV pulsed electron beam with mean dose-rates, ranging from a few Gy/min up to thousands of Gy/s. Absolute dosimetry is investigated with alanine, thermo-luminescent dosimeters (TLD) and radiochromic films as well as an ionization chamber for relative stability. The beam characteristic and dosimetry are prepared for three different setups. ResultsA cross-check between alanine, films and TLD revealed a dose agreement within 3% for dose-rates between 0.078 Gy/s and 1050 Gy/s, showing that these dosimeters are suitable for absolute dosimetry for FLASH-RT. In absence of appropriate setup dependent corrections, active dosimetry can reveal dose deviations up to 15% of the prescribed dose. These differences reduce to less than 3% when our dosimetric procedure is applied. ConclusionWe developed procedures to accurately irradiate biological models. Our method is based on validated absolute dosimeters and extends their use to routine FLASH irradiations. We reached an agreement of 3% between the delivered and prescribed dose and developed the requirements needed for workflows of preclinical and clinical studies.

Benefit-cost analysis and application of intelligent compaction for transportation

Abstract Conventional test methods for roadway compaction cover less than one percent of roadway; whereas, intelligent compaction (IC) offers a method to measure 100 percent of a roadway. IC offers the ability to increase compaction uniformity of soils and asphalt pavements, which leads to decreased maintenance costs and an extended service life. This paper examines IC technology, how IC quality control and assurance specifications can encourage IC adoption, knowledge and use of IC through survey responses, and benefits and costs of IC. The surveys reveal that a majority of respondents from state departments of transportation have conducted IC demonstration projects, but questions about cost and willingness of policymakers to adopt IC remain a barrier to implementation. The benefit-cost analysis demonstrates that use of IC reduces compaction costs by as much as 54 percent and results in a US$15,385 annual savings per 1.6 km throughout the roadway’s life. The framework of the benefit-cost analysis can be readily adopted by transportation agencies to facilitate the implementation of intelligent compaction in future roadway construction.

Specification Limits and Pay Adjustment for Longitudinal Joint Density of Asphalt Pavements: Case Study in New Jersey

This paper summarizes a case study on developing specification limits and pay adjustments for the longitudinal joint density of asphalt pavements. The existing joint density specifications used by various agencies first were reviewed for the minimum joint density requirements and the corresponding pay adjustments. Laboratory tests were conducted to measure air voids of field cores taken from selected field projects with the saturated surface dry method (AASHTO T 166) and the automatic vacuum-sealing method (AASHTO T 331). Permeability measurements were conducted with a falling-head permeability device. The air voids at the joint were found to be 1.5% to 2% greater than the air voids at the mats adjacent to the joint. For conditions specific to New Jersey, individual testing of the theoretical maximum density of the cores taken at the joint is recommended because of the existence of joint adhesive. The upper limits for air voids at the longitudinal joint are recommended to be 9% for stone matrix asphalt and 10% for hot-mix asphalt, on the basis of the permeability criterion of 150 × 10−5 cm/s reported in previous studies. Furthermore, alternative pay equations for air voids at the longitudinal joint were proposed, with different triggers for retest and for rejectable quality level. A SpecRisk analysis was conducted to confirm that the effective acceptable quality level coincided with the stated acceptable quality level and that the acceptance procedures properly awarded 100% payment at the stated acceptable quality level. The study led to a draft quality assurance specification for longitudinal joint density that was proposed for future implementation.

Comparison of physical quality assurance between Scanora 3D and 3D Accuitomo 80 dental CT scanners

BackgroundThe use of cone beam computed tomography (CBCT) in dentistry has proven to be useful in the diagnosis and treatment planning of several oral and maxillofacial diseases. The quality of the resulting image is dictated by many factors related to the patient, unit, and operator.Materials and methodsIn this work, two dental CBCT units, namely Scanora 3D and 3D Accuitomo 80, were assessed and compared in terms of quantitative effective dose delivered to specific locations in a dosimetry phantom. Resolution and contrast were evaluated in only 3D Accuitomo 80 using special quality assurance phantoms.ResultsScanora 3D, with less radiation time, showed less dosing values compared to 3D Accuitomo 80 (mean 0.33 mSv, SD±0.16 vs. 0.18 mSv, SD±0.1). Using paired t-test, no significant difference was found in Accuitomo two scan sessions (p>0.05), while it was highly significant in Scanora (p>0.05). The modulation transfer function value (at 2 lp/mm), in both measurements, was found to be 4.4%. The contrast assessment of 3D Accuitomo 80 in the two measurements showed few differences, for example, the grayscale values were the same (SD=0) while the noise level was slightly different (SD=0 and 0.67, respectively).ConclusionsThe radiation dose values in these two CBCT units are significantly less than those encountered in systemic CT scans. However, the dose seems to be affected more by changing the field of view rather than the voltage or amperage. The low doses were at the expense of the image quality produced, which was still acceptable. Although the spatial resolution and contrast were inferior to the medical images produced in systemic CT units, the present results recommend adopting CBCTs in maxillofacial imaging because of low radiation dose and adequate image quality.

The Use of the Dynamic Cone Penetrometer for Quality Control of Compaction Operations

The use of a new quality control (QC) and quality assurance (QA) specification involving Dynamic Cone Penetrometer (DCP) testing in concert with conventional moisture and density testing is becoming more and more frequent in various parts of the world. The need for this additional testing is essential, as the regular in-situ density tests cannot alone ensure the compliance of the layers constructed with the compaction requirements. Recent analyses of the correlation between the DCP testing and the California Bearing Ratio CBR testing show that QC and QA DCP testing is adequate to verify compaction, stability and vertical uniformity in both cohesive and granular soils. Two examples of DCP usage in two Israeli earthwork projects, one of clayey soils and the other of silty-sand soils, indicate the benefits of this usage along with, though for the clayey example only, Falling Weight Deflectometer (FWD) testing.

Technology Innovation of Used Automotive Electronic Control Components Recycling in China

The unreasonable treatment of used automotive electronic control components can result in great damage to the environment and resource wastage. Therefore, there is an extremely urgent demand to develop a recycling program for these components. The Chinese scholars are developing the used automotive electronic control components recycling research. The recycling key technologies include: non-destructive high-efficiency dismantling and green clean technology, test technology and equipment, adjust technology, reliability testing techniques and quality assurance specifications. This study introduces the latest developments of these key technologies in accordance with China’s actual conditions, and then discusses the development direction.

Obligatory translation shift as a sub-component of a model of quality assurance specifications and performance translator assessment

The paper deals primarily with obligatory translation shifts involving translating English texts from and into Arabic and specifies the sub-components of a proposed model of quality assurance specifications and performance translator assessment. Obligatory shifts involve substituting English non-finite embedded forms with finite ones, lexicalizing certain grammatical elements, making agreement in gender between Arabic adjectives and nouns and Arabic nouns and verbs, substituting emphatic ‘do’ with the appropriate rhetorical device, supplying an antecedent to the translated Arabic relative constructions, transposing English initial noun clauses and sentence modifiers to post-verbal positions, placing the definite noun rather than its referent in initial positions, rendering certain English adjectives into verbs, nouns or adjectival clauses, replacing existential ‘there’ and the English grammatical subject ‘it’ with the appropriate corresponding forms, substituting the English comma with the Arabic conjunctive ‘wa’-and or ‘aw’-or as a linking device, deleting the corresponding form of copula be in Arabic interrogatives and replacing certain English noun modifiers with the appropriate similitude construction. The proposed model of quality assurance specifications and performance translator assessment examines the communicative, situational, semantic, structural, stylistic, pragmatic, textual, aesthetic, rhetorical, lexical and informational aspects of the translated text which are essential for assessing the quality of the text and the performance of the translator.

Field Assessment and Specification Review for Roller-Integrated Compaction Monitoring Technologies

Roller-integrated compaction monitoring (RICM) technologies provide virtually 100-percent coverage of compacted areas with real-time display of the compaction measurement values. Although a few countries have developed quality control (QC) and quality assurance (QA) specifications, broader implementation of these technologies into earthwork construction operations still requires a thorough understanding of relationships between RICM values and traditional in situ point test measurements. The purpose of this paper is to provide: (a) an overview of two technologies, namely, compaction meter value (CMV) and machine drive power (MDP); (b) a comprehensive review of field assessment studies, (c) an overview of factors influencing statistical correlations, (d) modeling for visualization and characterization of spatial nonuniformity; and (e) a brief review of the current specifications.

SU‐FF‐T‐472: Quality Assurance for MR Guided Focused Ultrasound as a Multi‐Modality Platform for Cancer Therapy

Purpose: The purpose of this work is to develop an effective and efficient quality assurance (QA) program for the application of MR guided focused ultrasound (MRgFUS) as a multi‐modality platform for cancer therapy. Materials and Method: An MRgFUS system has been installed in our institution, which consists of an InSightec ExAblate 2000 high‐intensity focused ultrasound (HIFU) system and a 1.5T GE MR scanner. This system has been FDA approved for the treatment of uterine fibroids clinically and is being investigated under local IRB approval for treating bone metastases, prostate and breast cancers and the enhancement of drug delivery for gene therapy and chemotherapy. In addition to the daily, monthly and annual calibration and commissioning measurements for the MRI unit special QA procedures were developed for the HIFU system including the mechanical motion of the couch and transducer, the safety system and patient panic buttons, the functionality of the temperature mapping and treatment software, the acoustic power output and the localization of the treatment focal spot. Results: The MRgFUS system has been operational since the fall of 2006. Successful experiments have been performed on in vitro bio‐samples and in vivo animal models for pre‐clinical studies and for drug enhancement experiments. Patients with bone metastases have been treated successfully using the MRgFUS system for pain relief with a pre‐treatment QA procedure. Patients tolerated the HIFU treatment well. No skin damage was observed after treatment. The pain scale was significantly reduced within 24 hours and further reduced at later follow‐ups. Conclusions: Comprehensive QA procedures have been developed for the safe and successful operation of the MRgFUS system as a multi‐modality platform for breast surgery, bone palliation, and prostate boost in combination with radiotherapy clinically and for drug delivery enhancement investigations for gene therapy and chemotherapy using animal models.