Vention Medical

Our work doesn't end with ideation and design. We guide and support our medical device partners from Concept to ClinicalSM — to help our customers advance their medical device innovations efficiently and effectively.

With an on-site team committed to the highest quality systems and process standards, and deep expertise in navigating the complex regulatory environment, we offer a rigorous approach designed to move you from product design and development through clinical studies.

Additionally, we are ISO 13485:2003 registered through BSI, and feature a full quality system that also complies with FDA's 21 CFR Part 820. We are also ISO 14971 Certified to Risk Management.

Whether as a stand alone project or part of a larger engagement, our broad range of quality system activities and regulatory affairs services include:

• Customization of a quality system to meet your specific needs and business objectives
• Development of procedures and processes to support your project
• Regulatory submission support, including drafting of submissions
• Oversight and ongoing support of your contract sterilization vendors
• Programs for biocompatibility and sterility testing
• Document control through the Document Change Order process
• Completed documentation packages, including:
  • Design History Files
  • Device Master Records
  • Pre-market Approval Documents