- Speaker : José Mora
- Session Code : JMAUG1121
- Date : 11th August 2021
- Time : This Event is Over and the Recorded Copy is Available
- Duration : 1 Hour 19 Mins
Risk Management for Medical Devices per ISO 14971:2019
Overview:
Risk
management overarches projects associated with a particular product family,
given that risks will both remain and change as new design features and medical
indications for use evolve with a particular device.
During
all phases of a project, any new consideration must be held up against the
scrutiny of potential risk and harm to the health of people, damage to
property, or to the environment during all stages of a product’s life cycle and
supply chain.
Risk
management is a process that involves many considerations, responsibilities,
personnel, and the transfer of knowledge.
Given that it transcends projects and even companies, it is particularly
critical that key pieces of information survive these many hand-offs.
Areas Covered in the Session:
- Risk
management process as per ISO 14971
- Management
responsibilities
- Qualification
of personnel
- Risk
management plan
- Risk
management file
- Bringing
it all together – links to design and process
Who
Should Attend?
ISO 14971:2019 has
introduced significant changes including benefit, reasonably foreseeable misuse
and state of the art, as well as the management of risks associated with
medical devices. It is important to be aware of these changes as technology
continues to emerge.
If you are constantly
struggling to create, manage, and maintain all of the information found in the
various Risk Management documents and files, all of which are often redundant,
repetitive, and clustered together in an awkward manner, this webinar is something
that will give you a different perspective and a very different approach that
you can use.
If your design and
manufacturing resources are spending too much time on documentation and not
enough time on actual risk management and mitigation, you as a manager need to
be looking for ways to simplify the work at hand.
Who
will benefit:
Medical
device and combination product biotechnology devices
Managers,
Supervisors, Directors, and Vice-Presidents in the areas of:
- R&D
- Manufacturing
Engineering
- Design
Assurance
- Quality
Assurance
- Operations
- Document
Control
José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem-solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.
José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices.
José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter.
His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles.
During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits.
Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose’s leadership. He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.
Enrollment Options
Tags: Risk Management for Medical Devices per ISO 14971:2012, Jose Mora, Webinar, August 2021, Amorit Education