DAY ONE | WEDNESDAY, DECEMBER 4
7:45 REGISTRATION & WELCOME COFFEE
8:30 CHAIRPERSON’S OPENING REMARKS
8:45 ICEBREAKER: DIVISION OF MDR IMPLEMENTATION RESPONSIBILITIES
While the MDR introduces a wide variety of updates that must be made to manufacturer’s internal processes, medical device companies have taken different approaches to divvying up the associated workflows. Implementation tasks such as new labeling standards, design control and cooperation with notified bodies have been assigned to different teams depending on a company’s size and resource availability. Following a discussion on how one company determined ownership of implementation projects, delegates will convene and share methods for allocating responsibilities and how the role of quality assurance is being defined when it comes to EU MDR implementation.
9:30 PANEL: NEW HIRES AND CONSULTING TEAMS: OPTIMIZING STAFF FOR EU MDR IMPLEMENTATION
Updating procedures to comply with the EU MDR has required quality assurance professionals to develop new workflows that require attention beyond the bandwidth of established teams. The vast number of requirements has resulted in a need to reevaluate levels of staffing and workload priorities to balance existing responsibilities against preparations for MDR compliance, leading many teams to consider onboarding new staff members, or outsourcing functions to consultant partners. Whether a short term solution of an outside consultant or the in-depth expertise of a permanent hire, new perspectives are being sought to guide the development of compliant procedures.
- Recognizing staffing needs and limited employee resources
- New workflows and onboarding hires for permanent roles
- Need for outside perspectives and consulting professionals
Tammy Lavery, MAXTEC
Colleen Watson, VYAIRE
10:30 COFFEE AND NETWORKING BREAK
11:00 CASE STUDY: STAGED APPROACH TO RISK MITIGATION WHILE LEVERAGING THE REMAINING IMPLEMENTATION TIMELINE
The wide breadth of the EU MDR lays out a number of implementation requirements that must be updated along certain timelines, however, the timelines of the certifications can vary depending on the product classification and MDD certification. An in-depth understanding of specific implementation deadlines is an extremely useful asset when prioritizing work flows, while determining associated risks and some quality professionals have already found ways to leverage the remaining transition period as an advantage. With a focus on how organizations can best update quality management systems in order to align compliant procedures before next year’s deadline, this session provides a comprehensive look at the remaining timelines and how they apply to different sectors of the business.
Ronak Dunung, Manager, Risk Management, COOK MEDICAL
11:45 QUALITY MANAGEMENT SYSTEM REQUIREMENTS & EXPECTATIONS FOR SUPPLY CHAIN ECONOMIC OPERATORS
- QMS requirements for importers, distributors and authorised representatives in the MDR;
- QMS expectations from competent authorities and manufacturers
- QMS requirements for importers and finished device manufacturers (including contract manufacturers)
- FDA Compliance in a MDSAP World (and potential ISO Alignment)
Fabien Roy, Partner EU Regulatory & Life Sciences, HOGAN LOVELLS
Dennis Gucciardo, Counsel, HOGAN LOVELLS
12:30 LUNCHEON FOR ALL PARTICIPANTS
1:30 CONDUCTING GAP ANALYSIS THROUGH A SIMULATED CERTIFICATION PROCESS
As more companies work to implement MDR compliance into standard practices, new methods of regulatory gap analysis are being developed to safeguard against aspects of the regulation that may have been overlooked. Some companies, with the assistance of outside consultants who can provide greater objectivity are simulating the full certification processes to identify remaining issues that could interrupt the notified body certification. By understanding how fellow quality professionals managed the development of internal interpretations to conduct a certification audit, delegates will gain a concrete understanding of what goes in to CE mark evaluations.
Tammy Lavery, Director Regulatory & Quality Affairs, MAXTEC
2:15 ALTERATION OF CERTIFIED LABELING & PACKAGING PROCEDURES IN COMPLIANCE WITH EU MDR
The EU MDR requires an array of revisions and updates to be implemented into medical device labeling systems. With new standards for translations, shipping labels and UDI, many quality assurance teams are grappling with integrating these changes into a previously certified labeling process and must alter the manufacturing of a device to meet MDR compliance. As the 2020 implementation deadline draws near, it is vital for quality teams to be attentive to the full range of new requirements and proactively take steps to ensure labeling processes can be transitioned with little interruption.
- Comparing new requirements with previous legislation
- Transparency’s link to value-based pricing
Mark Zellers, Quality Assurance Specialist, STRYKER
3:00 COFFEE AND NETWORKING BREAK
3:30 PANEL: ENSURING PRECISE TRANSLATIONS WHILE IMPLEMENTING MDR LABELING STANDARDS
Under the MDR, companies are required to provide important safety information on a device’s label and ensure its readability to all people within the European Union. This requires device labels be translated to more than twenty languages, introducing significant risks to patient safety if the translations are misleading or incorrect. For quality professionals undertaking MDR implementation, ensuring precise translations with available staff and resources can seem daunting. For a look at how quality teams have approached the question of managing translations across a company’s product line, a panel of experts will speak to ways this sizable task can be achieved.
Erin Salbilla, VYAIRE
Mark Zellers, STRYKER
4:15 MANAGING NEW QUALIFICATIONS AND REGULATIONS ON MDR HAZARDOUS MATERIALS THROUGHOUT THE SUPPLY CHAIN
While quality teams have always worked closely with suppliers to implement regulated design controls, the new standards for hazardous materials under the EU MDR require a stricter and more thorough assessment of a device’s intricate supply chain. In addition to the composition of device components, quality professionals also need a clear understanding of the chemical processing and manufacturing environments that produce these parts. It is imperative that quality professionals have a detailed look at these newly restricted materials, including cobalt, CMRs and phthalates, how to track usage throughout a device’s development and methods for determining if usage can be justified to a notified body.
- Overview of new hazardous material classifications under the MDR
- Methods for detection and composition throughout the supply chain
- Documenting justification to notified bodies for usage of restricted materials
Maya Uddin, Technical Innovator, Project Manager, W.L. GORE & ASSOCIATES
Jolene Hernandez, Divisional Quality & Process Engineer, W.L. GORE & ASSOCIATES
5:00 END OF DAY ONE CONFERENCE