Developing a medical product — a medical device, a pharmaceutical, or a combination product — is a long, costly, and regulatorily demanding process. Early decisions (opportunity selection, user-needs definition, translation into engineering requirements, regulatory-pathway selection, clinical-evidence plan) determine whether a program reaches the market on time or stalls. The industry has developed structured methodologies — Cooper’s stage-gate process, the FDA Design Controls under 21 CFR §820.30, ICH Q8 Quality by Design — to manage this complexity with cross-functional discipline.

This 16-hour Professional Certificate Course is the entry point of the Aleph Medical Product Development Process course track. It introduces stage-gate methodology adapted to medical products; innovation and discovery; the FDA Design Controls framework (21 CFR §820.30) at orientation depth; ICH Q8 Quality by Design at orientation depth; verification and validation orientation; and the regulatory-approval planning that connects product development to submission strategy. The course also introduces the integration of risk management (ISO 14971 for devices, ICH Q9 for pharmaceuticals) into the stage-gate process.

The course prepares participants for the Advanced level (`RAQ-600-A`), where the same content is exercised at applied depth — applied stage-gate plan authoring, applied recall case analysis, applied integrated risk-management decisions, applied V&V planning, applied regulatory-pathway selection, and a complete medical-product development plan. Together the Introductory and Advanced levels form a 48-hour course track.

The Introductory course establishes the product-development vocabulary the regulated industries expect of someone working in product leadership, regulatory strategy, R&D management, or quality program leadership. Employers in this space include medical-device and pharmaceutical manufacturers across all categories, medical-product startups, and consultancies serving manufacturers on product-development planning.

Participants who meet the course completion requirements receive a Certificate of Completion issued by Aleph University.