Beaupre Consulting

Derek Beaupre - Principal

Over30 years of medical device product development expertise for start-up companies.

• Product Development – comprehensive experience from concept through commercialization for various class I-III medical products including capital equipment, reusable, disposable and implantable devices.

• Project Management – lead project teams for product development, mechanical design projects, product verification and clinical validation, and equipment installations including clean room setup.

• Mechanical Engineering/Design – numerous projects using design for manufacturing and assembly including sliding patient treatment table; handheld electromechanical instruments; disposable products including cell sorting cartridge with microfluidics chip, minimally-invasive probes, infusion devices, and sharps containers. Materials selection includes stainless steels, titanium and aluminum alloys, thermoplastics and thermoset polymers, and bioabsorbables.

• Quality Assurance – Failure Modes and Effects Analysis; hazard/safety analysis; reliability engineering; software validation; internal Quality auditing; FDA Master File and 510(k) submissions; writing and implementing a Quality Systems Manual and Standard Operating Procedures for ISO/CE Mark certification and compliance with FDA Quality System Regulations.

• Regulatory Affairs - Received regulatory clearance as author of two 510(k) submissions and supported several other 510(k)s, an IDE and a Master File.  Compiled technical files to obtain numerous CE Mark approvals.

• Manufacturing Engineering – transferred multiple product lines from Massachusetts to California; process verification; pilot production and design transfer to manufacturing; cleanroom and manufacturing line setup; fixture and equipment design, installation, and validation.

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