WHAT WE DO
The QRC Group offers an affordable lean solution to building the organizational structure, resources and planning necessary for you to achieve sustainability while accelerating product commercialization.
The QRC Group is experienced in all facets of the commercialization process serving domestic and international medical device industry markets.
Three Actions to Accelerate Product Commercialization
- Quality Systems – Building a tailored approach to your QMS that meets the needs of your product’s risk profile. There is no “one size fits all” approach to quality.
- Regulatory Affairs – Providing strategy from concept through to commercialization to ensure that all of the development work is on target to meet regulatory requirements.
- Compliance – Maintaining a well-run QMS requires the ability to continually meet new requirements. We help you sort out any gaps you have or get ahead of upcoming compliance changes.
SERVICES
- Quality Training
- Perform Internal Audits
- DHF/Technical File Creation
- Acting (Management Representative)
- Market Access – Health Canada, 510(k), EU CE Marking
- Regulatory Registration & Listing
- Marketing & Advertising Review
SPECIALITIES
- Internal and External Audits
- Research & Regulations
- FDA & Notified Body Liaison
- Writing & Communications
- Substitute Management for Start Ups