Compliance Architects® is proud to be a sponsor of this year’s American Medical Device Summit in Chicago, Illinois. Setting the standard on how the industry should connect and exchange ideas, the American Medical Device Summit provides insights and strategies to enhance the professional development of executives involved in the design, product development, innovation, technology and quality/ regulatory aspects of medical devices.
CEO Jack Garvey is excited to be leading a breakfast roundtable discussion about risk assessment in device development/launches on day two of the event.
Over 250 industry leaders explore the challenges and opportunities in medical device innovation, regulatory harmonization, compliance, digital transformation and more. Hear first-hand case studies presented the executive speaker faculty with extensive experience driving development and process strategy excellence. Walk away with strategic insights for industry, hopital networks and regulatory bodies to colloborate together to streamline processes, optimize development, design, decrease risk, improve speed to market, reduce costs, and remain compliant in a rapidly evolving landscape.
- Recognize the impact of public policy on the medical device industry in terms of global market expansion and competitiveness
- Leverage innovation to accelerate speed to market while reducing risk
- Utilize your post-market surveillance system to feed your risk management and product lifecycles
- Identify the opportunities and challenges in various regulatory markets, alongside an analysis on potential modifications to 510k policy
- Create a successful partnership with suppliers and contract manufacturers
- Reduce up-front investment and market risk through effective and frequent prototyping early in the development cycle
- Incorporate performance, safety, business economics, risk management, and regulatory requirements as a basis for device design
- Apply ‘Design Thinking’ as a driver for medical device development
- Ensure the design of the medical device can be correctly translated into production specifications
- Understand the impact EU MDR and increased harmonization in the medical device Industry
- Preparing for the next generation of medical devices and embracing value-based health care
- Develop and sustain the gains of a quality culture and adopt proven change management techniques