David Violette Email & Phone Number

Oxford, MA, US

• Identify applicable FDA requirements
• Prepare risk & compliance assessment reports
• Communicate regulatory and process requirements
• Identify applicable assessment standards and tests for FDA, EU & ISO
• Correspond with FDA and prepare documentation for submissions
• Review and generate indications and instructions for use, device labeling and web site content

Marlborough, MA, US

Responsible for the compliance of products and design of subsystems. Provide guidance to teams and departments on design and compliance issues related to safety, EMC, quality and reliability. Support design transfer and field deployment. Participate in the preparation of Hazard/Risk Management documentation. Primary interface to safety agencies and test.

Bristol, CT, US

Advise and assist regarding compliance of existing and new products to FDA requirements.

Plainview, New York, US

Identified European compliance requirements. Prepared risk analysis, compliance assessment reports, and test protocols/plans. Identified test needs and qualified test lab vendors. Reviewed design and documentation and suggested design and process changes that would improve safety, performance, and reliability. Achieved compliance with European requirements.

Responsible for all product test, compliance and Quality/Engineering processes and procedures in this medical device start-up. Created Quality and ISO training program. Created controlled design and documentation system. Identified compliance requirements and prepared strategy and project plan for accessing global markets.

Created and managed a mechanical engineering department, managed engineering labs, documentation department and all product compliance.

Project manager and technical lead of all product safety and compliance.