Sample Report - Technical File Review
Pre-assessment Audit of Technical File April 7, 2014 1.0
Prepared for:
Vice President of Regulatory and Clinical Affairs
ABC Medical Products Written by:
Ronald Sills, Nerac Analyst
©2013 Nerac, Inc. | One-Technology Drive | Tolland, CT 06084 | 1-860-872-7000 | www.nerac.com
Sample Report
Technical File Review
April 7, 2014
1.0
Table of Contents 1.
2. 3. 4. 5. 6. 7.
Executive Summary ................................................................................................................. 3 1.1. Goals and Objectives........................................................................................................ 3 1.2. Conclusions ...................................................................................................................... 3 1.3. Recommendations ........................................................................................................... 3 Methodology ........................................................................................................................... 3 Results...................................................................................................................................... 4 Appendix .................................................................................................................................. 6 Bibliography ............................................................................................................................. 7 About the Analyst .................................................................................................................... 8 Terms and Conditions ............................................................................................................ 11
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Technical File Review
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1. Executive Summary 1.1. Goals and Objectives The ABC Medical Company is a worldwide leader in the design, manufacture and distribution of wound care devices and wound management systems. Their product line includes moist dressings, silver-impregnated dressings, and debridement devices. The products are assembled into technical files as product families, based on their classification per the Medical Devices Directive 93/42/EEC 2007, Annex IX. The company has requested Nerac perform a preassessment audit of the debridement devices, which are a Class IIb product family. The goal of the Nerac audit is to assess compliance with the essential requirements of the MDD and with the company’s quality management system (QMS) certification per EN ISO 13485:2012. The outcomes of this audit and any corrective or preventive actions implemented will help to prepare the company for an audit of the technical file and QMS by their notified body.
1.2. Conclusions A thorough review of TF-001 shows that the file does not meet the essential requirements of the MDD 93/42/EEC. Three minor non-conformities and one major non-conformity are documented in the results section of this report. The minor non-conformities are documented against the areas of risk management, sterilization validation and clinical evaluation. The major non-conformity is documented against the area of engineering usability.
1.3. Recommendations As a result of the non-conformities documented, it is recommended that corrective and preventive action plans are established to correct the deficiencies, eliminate the root causes, and to bring the technical file into full compliance with the MDD. Nerac also recommendeds areview of other technical files to identify any similar deficiencies.
2. Methodology The scope of this Nerac audit was the technical file TF-001 ABC Medical Company Wound Debridement Devices for compliance with the MDD 93/42/EEC 2007 essential requirements and the company’s QMS procedures pertaining to the process used to design, manufacture, and distribution of these devices. The company has chosen a conformity assessment route per Annex II, excluding section 4, which pertains to design dossiers for Class III products. The audit was conducted over a 3 day period Apr 1-3, 2014, and included the review of all sections of the technical file, as well as the QMS procedures, which specify the processes and
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activities to complete each section. The Appendix section of this report contains a list of all procedures and records reviewed. Audit findings are documented in this report as non-conformities, observations, or opportunities for improvement. Non-conformities may be graded as major minor depending on their extent and severity. A major non-conformity represents the failure to establish a documented process for an activity which is required by the QMS standard EN ISO 13485:2012, or as required by the MDD. A major non-conformity may also represent a systemic breakdown in compliance with a documented QMS procedure, or any compliance failure which may directly impact product or patient safety. A minor non-conformity may represent an isolated failure to comply with a specified requirement. All non-conformities shall require a corrective action plan including immediate correction or containment, root cause analysis, and corrective or preventive action. An observation may represent an instance where compliance may not be fully demonstrated however, insufficient evidence is available to make a full determination. An opportunity for improvement may represent a process or activity that can be improved upon to strengthen the compliance to the standard and the directive. Observations or opportunities for improvement do not require a formal corrective action plan however should be discussed by upper management to determine any improvements to the QMS or technical file. All applicable sections of the technical file and QMS were reviewed and are summarized in the results section of this report. Audit findings and recommendations are included in the summary and conclusions sections of this report.
3. Results The following sections of the technical file TF-001 were audited. Findings for each section are summarized. Section 1 – Device Description The debridement devices include a forceps, scissors, scalpels and a NdYag laser. The forceps, scissors and scalpels are provided sterile, for single-use only. These components are sterilized with 100% ethylene oxide (EO). The NdYag laser is provided non-sterile and is intended for multiple uses. The debridement devices are classified as IIb, per MDD Annex IX Rule 4, as they are intended to be used principally with wounds which have breached the dermis and can only heal by secondary intent. Section 2 – Packaging and Labeling Labeling is provided in accordance with EN 980 and EN 1041. Section 3 – Risk Management Plan
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The risk management report was documented in 2012 upon initial release of the product family. Non-conformity (minor) – the risk management report has not been updated with the post market surveillance since 2012 as required by SOP-102. Section 4 – Biocompatibility Evaluation The debridement devices were evaluated for biocompatibility per ISO 10993-1 criteria. The devices were tested by Namsa laboratories for cytotoxicity, sensitization, and hemocompatibility. Observation – the biocompatibility tests were not conducted on devices which were first sterilized with EO. Section 5 – Sterilization Validation Report The EO sterilization process is re-validated annually by a half cycle and full cycle. Required tests are package integrity, Eo residuals, bioburden and product sterility, and product functionality. Non-conformity (minor) – the package integrity tests (peel strength and dye penetration) were not completed as required by SOP-103. Section 6 – Clinical Evaluation Report The clinical evaluation report is updated annually by a review and analysis of the clinical literature and the post market data from customer complaints, adverse event reports and customer surveys. The report is performed in accordance with MEDDEV 2.7.1 Rev 2. Non-conformity (minor) – The evaluation of adverse events does not include a review of competitive devices. The equivalency of the devices reviewed in the literature to the company’s devices is not justified. Section 7 – Post Market Surveillance Report The post market surveillance data is presented during management review. The data is used to re-evaluate the risk management report and the clinical evaluation report. Section 8 – Declaration of Conformity The declaration of conformity is documented in accordance with MDD Annex II full quality assurance system. Other: Non-conformity (major): There is no documented evidence of conformance to EN 62366 to fulfill the requirements for engineering usability.
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4. Appendix The following procedures and records were reviewed for the pre-assessment audit: QM-001 Quality Manual SOP-100 Management Review SOP-101 Control of Documents and Records SOP-102 Risk Management Process SOP-103 Sterilization Validation Process SOP-104 Clinical Evaluation SOP-105 Corrective and Preventive Action Process SOP-106 Handling of Customer Complaints SOP-107 Post Market Surveillance DOC-100 2014 Management Review Meeting Minutes DOC-101 Risk Management Plan for Debridement Devices DOC-102 2014 Sterilization Re-validation of Debridement Devices DOC-103 2014 Clinical Evaluation Update for Debridement Devices DOC-104 Packaging Validation Report for Debridement Devices DOC-105 Biocompatibility Evaluation Report for Debridement Devices
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5. Bibliography The following documents were used as the basis of the pre-assessment audit: Medical Device Directive MDD93/42/EEC 2007 EN ISO 13485:2012 Medical devices -- Quality management systems -- Requirements for regulatory purposes EN ISO 14971:2012 Medical devices -- Application of risk management to medical devices EN 60601-1:2006 Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes EN 980:2008 Symbols for use in the labeling of medical devices EN 1041:2008 Information supplied by the manufacturer with medical devices EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process EN ISO 10993-7:2008 + AC:2009 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals EN 62366:2008 Medical devices – Application of usability engineering to medical devices EN ISO 11135-1:2007 Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices EN ISO 11737-1:2006 Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products EN ISO 11737-2:2009 Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice MEDDEV. 2.7.1 Rev.3, 2009 Guidelines On Medical Devices - Clinical Evaluation: A Guide For Manufacturers And Notified Bodies
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6. About the Analyst Ron Sills “The global regulatory landscape for medical device manufacturers’ registrations and product approvals continues to evolve at a rapid pace. While many countries strive towards harmonized regulations there remain distinct regulatory requirements specific to country or product classification. Device manufacturers must keep pace with this dynamic industry in order to maintain compliance and grow their place in the market.” Ron Sills works strategically with medical device companies to review business goals and objectives and offer information management solutions and analysis. By providing custom briefings to monitor the medical device industry, assess the competitive landscape, and track product safety, he proactively enhances executives’ ability to make informed decisions. As a manager of quality and as an R&D engineer at Circon ACMI before joining Nerac, Mr. Sills gained keen insight into developing a product and bringing it to market, with the accompanying responsibilities and regulatory requirements of a medical device organization. His expertise includes materials requirements, design development and validation, regulatory guidelines, manufacturing processes, and marketing and sales strategies. As a certified Lead Auditor for TUV Rheinland of North America, Ron has assessed the quality systems and product safety requirements of numerous medical device manufacturers for compliance with EN ISO 13485, the Medical Devices Directive and the Canadian Medical Devices Regulations. Mr. Sills, who holds a master’s degree in biological sciences from Southern Connecticut State University, teaches microbiology at Naugatuck Valley Community College. Mr. Sills co-chaired the four-day conference track on combination products during the 2007 Medical Design & Manufacturing (MD&M) East show in New York City, and similar one-day tracks at the MD&M West in Anaheim, Calif., January 2008 and the MD&M Midwest in Minneapolis in October, 2008. He is a member of the Regulatory Affairs Professional Society.
Areas of Expertise Medical technology Medical devices Pharmaceuticals, combination products, wound healing and wound management Regulatory Compliance and Quality assurance: ISO 9001, EN ISO 13485, MDD, CMDR Sterilization techniques and validation Infectious diseases, microbiology
Industries Medical device Pharmaceutical Life Sciences
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Credentials M.S., Biological Sciences, Southern Connecticut State University B.S., Biological Sciences, University of Connecticut Member, Regulatory Affairs Professional Society (RAPS) Member, Association for the Advancement of Medical Instrumentation (AAMI)
Publications Sills, R, “Combination Products: Balancing Innovation with Time to Market is often a Matter of Addressing the Appropriate Regulatory Process”, Nerac Insights, http://www.nerac.com/nerac_insights.php?category=articles&id=116, September 2008 Sills, R, “Detecting MRSA: Newly Developed Rapid Diagnostics Help Stop the Spread of Disease”, Nerac Insights, http://www.nerac.com/nerac_insights.php?category=articles&id=32, January 2008 Sills, R, “A Sum Greater Than Its Parts: For Combination Products There Is Profitable Growth Beyond Stents”, Nerac Insights, http://www.nerac.com/nerac_insights.php?category=articles&id=247, 2007 Sills, R, “Evaluating Clinical Data: European Commission Issues New Guidelines For Literature Reviews”, Nerac Insights, http://www.nerac.com/nerac_insights.php?category=articles&id=249, September 2007 Sills, R, “Raising the Bar: Approvals Will Be Harder To Get, But User and Patient Safety Will Improve with New Standards”, Nerac Insights, http://www.nerac.com/nerac_insights.php?category=articles&id=243, June 2007 Potash, G, Sills, R, “Accelerated Growth in Wound Care”, Nerac Insights, http://www.nerac.com/nerac_insights.php?category=reports&id=12, November 2007 Presentations Sills, R, “Developing and Marketing Your Combination Product”, Nerac webcast , Sills, R, “Combination Medical Device Product Strategies”, Nerac webcast , Sills, R, “Combination Products: A Convergence of Technologies and Market Opportunities”, Nerac webcast , Sills, R, Host panel discussion “Combination Products: A Convergence of Technologies and Market Opportunities” MD&M, Minneapolis, MN, Oct 21-23, 2008
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Sills, R, “Combining Market Intelligence with Technology: Critical Considerations for Entering the Profitable Space of Combination Products”; Chair, “Combination Products: Strategic Partnering and Licensing”, MD&M West Conference and trade show, Anaheim Convention Center, Anaheim, CA, January 28-31, 2008
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7. Terms and Conditions This report is provided as a work made for hire subject to the terms of the master services agreement between Nerac and the individual or company to which or on whose behalf it is provided (“Company”). The recipient of this report shall abide by any copyright restrictions applicable to any sources cited in or accompanying this report. Nerac disclaims any and all warranties not expressly provided in the master services agreement between Nerac and Company. Company should independently analyze and verify the information contained in this report before making any use of it for any reason, including in making any investment decisions. This report does not constitute a recommendation to make or not make an investment. The recipient of this report accepts or rejects the findings represented in this report at its sole discretion. The terms of any investment decision, including the merits and risks involved, must be solely and independently analyzed by the client. The information contained in this report is believed by all its writers to be current as of the date of this report. Future events, changes or developments in science, law or fact cannot be predicted, and Nerac has no obligation to update this report with respect to .future events, changes or developments unless expressly agreed in writing between Nerac and Company Nerac shall not be liable for any loss, injury, claim, liability, or damage of any kind resulting in any way from Company’s or any other recipient’s use of this report other than as expressly provided in the master services agreement between Nerac and Company.
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