5 Things the Medical Device Industry Should Expect in 2017 (and how you can prepare)
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With all the new and proposed regulations in the past year, there is one thing you can bet on in 2017, change. From the new EU MDR and IVDR, to the new version of ISO 13485:2016, to the increased focus on risk management by regulatory bodies across the globe, you will need to begin preparing for it all. Specifically you will learn: - Expected changes coming at FDA (and how they affect you) - Quality inspection areas of concern - Steps you can be taking to prepare for the transition to ISO 13485:2016 - What to expect when it comes to the new EU MDR & IVDR - Tips on what to expect when putting together your FDA regulatory submission Watch the presentation here: https://www.greenlight.guru/webinar/2017-medical-device-industry-predictions
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5 Things the Medical Device Industry Should Expect in 2017 (and how you can prepare)
- 2. Who is Jon Speer • 18+ years in the med device industry • 40+ products to market • Speaker • Thought leader and regular contributor at Med Device Online, MedCity News, QMed, Quality Digest and other leading industry publications • Expert in implementing quality systems • Run one of the most popular blogs & the #1 podcast in the medical device industry • Founder and VP QA/RA greenlight.guru @creoquality @greenlightguru Jon.Speer@greenlight.guru +1 317 960 4280
- 3. greenlight.guru - The Only eQMS Software Designed Exclusively for the Unique Needs of the Medical Device Industry
- 9. http://www.medicaldesignandoutsourcing.com/donald-trump-6-questions-medtech- needs-to-ask/ 1. What comes after the ACA? 2. Will medical device regulation be reduced? 3. Is the medical device tax repeal going to be permanent? 4. Will healthcare get tort reform? 5. What will happen to Medicare and Medicaid?
- 10. CAPA
- 14. Overview • Integrates risk throughout the QMS and product life-cycle—risk-based decision-making • Move toward harmonization with US CFR, Brazilian law (ANVISA), CMDR (Canada), and other law (MDD, JPAL, TGA)—MDSAP • Additional linkage to documentation required for regulatory purposes • Integration of QMS software
- 15. Overview (cont.) • Emphasis on appropriate infrastructure • New references to other standards (usability, sterile barrier, etc.) • New sections on complaint handling and reporting to regulatory authorities • Clarity for auditing • Planning and documenting corrective action (without undue delay) and preventive action
- 16. List of Clauses Impacted • 1 Scope • 3 Terms and definitions • 4 Quality management system • 4.1 General requirements • 4.2 Documentation requirements • 5.6 Management review • 6.2 Human resources • 6.3 Infrastructure • 6.4 Work environment and contamination control • 7.1 Planning of product realization • 7.2 Customer-related processes • 7.3.2 Design and development planning • 7.3.3 Design and development inputs • 7.3.5 Design and development review • 7.3.6 Design and development verification • 7.3.7 Design and development validation • 7.3.8 Design and development transfer • 7.3.9 Control of design and development changes • 7.3.10 Design and development files • 7.4.1 Purchasing process • 7.4.2 Purchasing information • 7.4.3 Verification of purchased product • 7.5.1 Control of production and service provision • 7.5.2 Cleanliness of product • 7.5.4 Servicing activities • 7.5.6 Validation of processes for production and service provision • 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems • 7.5.8 Identification • 7.5.11 Preservation of product • 8.2.1 Feedback • 8.2.2 Complaint handling • 8.2.3 Reporting to regulatory authorities • 8.2.6 Monitoring and measurement of product • 8.3 Control of nonconforming product • 8.4 Analysis of data • 8.5.2 Corrective action • 8.5.3 Preventive action
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- 25. Why do we need a new regulation? • Emphasis on appropriate infrastructure • Concerns from regulators – addressing concerns from the various scandals • Address regulatory weaknesses (NBs, availability of information) to increase confidence • International harmonization – implementing GHTF/IMDRF • Problems on implementation – lack of resources and lack of harmonization at the EU level • Universal implementation across member states as a regulation
- 36. Bonus!
- 38. What is MDSAP? The concept of the Medical Device Single Audit Program is based on the premise of a company receiving a single regulatory audit of the company’s quality management system that will satisfy the requirements of multiple regulatory agencies. • Regulatory Agencies involved: • U.S. FDA • Therapeutic Goods Administration of Australia • Brazil’s Agência Nacional de Vigilância Sanitária • Health Canada • Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency • The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) are Official Observers
- 39. http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech- 160324-requirements-auditing-orar.pdf
- 42. greenlight.guru - The Only eQMS Software Designed Exclusively for the Unique Needs of the Medical Device Industry