The Design and Development process of Medical Devices aims to ensure that devices meet user needs, intended uses, and specified requirements. Design Controls apply to the entire medical device lifecycle and include the development planning, identification of design inputs, development of design outputs, verification and validation of the design, control of design changes (whether these occur before or after product release), the review of design results, transfer to production and of course the generation of appropriate records that demonstrates compliance with applicable regulations and standards.
Regardless of the target market, a good design and development process is essential to the regulatory compliance of Medical Device manufacturers. Inadequate product design documentation can delay Device regulatory applications, shorten the duration of existing certificates and licenses, and even trigger post market actions and penalties.
However, over and beyond compliance aspects, the true value of effective design controls expands to all areas of the business. An effective implementation of design controls within the Quality Management System drives clarity of action through the product lifecycle and transparency of information for decision making which can lead to less rework, higher product quality and safety, a better baseline for continuous improvements and reduced time to market.
This webinar covers the key phases of design and development for medical devices. We cover all key terms and requirements identified in quality systems standards and regulations (e.g. ISO 13485, MDSAP, 21CFR820), share our experience and provide practical tips for the implementation of each phase into a quality management system. The link between the process requirements and the establishment of good documentation practices which demonstrate regulatory and quality compliance is also highlighted.
In addition, as Medical Device technologies evolve, the use of software and Software as Medical Devices (SaMDs) is an increasing focus of the regulators, this webinar also covers the integration of software development into the design control framework and the manufacturer’s quality management system.
Senior Consultant and Device Consulting Manager
Jean joined the consultancy in early 2017, coming from the MedTech industry as an experienced Quality and Regulatory professional.
Spending the last 15 years in a range of highly regulated fields including the Medical Device, Mining, Aerospace and Automotive sectors, his prior roles include Regulatory Affairs Manager, Quality Assurance Manager, Project Manager and Product Development Engineer. He puts into practice his strong technical background and hands-on expertise to provide practical solutions to the challenges faced by his clients in any phase of their product lifecycle. He focuses on implementing strategies that meet business requirements and bring efficiencies, whilst meeting the strict regulatory obligations of our industry. Jean is a Certified Engineer from France and holds a Master’s Degree of Engineering (Mechanical). He received ASQ Certification for Auditing in 2013 and is bilingual in French and English.
Jean's expertise cover, Regulatory Strategic Planning, particularly in the USA, EU, Canada and ANZ markets, Product Development and Design Controls, Management Systems Auditing and Compliance as well as Product Lifecycle Management.
Quality Assurance Manager and Senior Consultant
Belinda has several years of experience in roles as Quality Assurance/Regulatory Affairs Manager for Australian medical device manufacturers, as well as large multi-national medical device companies. In her roles, she has been responsible for the on-time and within budget execution of several projects, through the effective application of Quality Management Systems (QMS) and hands-on organisation strategies during the entire development process, from concept to post-market.
Belinda is an experienced professional in the medical device industry and holds a Bachelor of Mechanical Engineering (Biomedical) (Hons) from the University of Sydney. Belinda has extensive technical understanding and experience in process validation (cleaning/packaging) and sterilisation validation, as well as comprehensive experience in auditing (regulatory, internal, supplier), statistical analysis, and project and risk management. Belinda is responsible for the Quality Management System and processes, whilst also providing external consultation to clients in regulatory compliance and development of Quality Management Systems compliant with ISO 9001, ISO 13485, MDSAP and 21 CFR 820.