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Six Steps to Design Planning Core Competency

 Product Management    Regulatory/Clinical Affairs    Research/Development/Design   

Mr. Packard will also present on Improving Supplier Scorecards.

The ability to get new, high-quality products to market quickly is the most important core competency for a company to develop. Learn how to improve the performance of your design teams by sharing best practices in design planning. These include how to organize your design plan for regulatory compliance, how to perform an internal audit of design controls and what aspects of the design process to measure as a quality objective. If you adopt these best practices, you will learn how to avoid project delays and your company will launch new products on time.

Session Takeaways:

• How to create a design plan
• Why you need to identify the regulatory pathway before you design the product
• What to measure in the design process
• When and how to perform internal audits of design controls
• How to use your CAPA process to improve the design process

Rob-Packard WEBRobert Packard
Medical Device Academy

Robert Packard is a regulatory consultant with 20 years of experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Mr. Packard served in senior management at several medical device companies, including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing and maintaining ISO 13485 and ISO 14971 certification. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Mr. Packard's specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others.