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.
Key learning objectives:
- The importance of effective planning and processes in design and development
- The correlation between standards and regulatory requirements and internal processes
- Integration of software development mechanisms into general design controls
- Key considerations for documentation in design controls
