Medgineering: your new core team.
Quality Systems
- Quality Systems from Scratch™
- FDA 21 CFR 820 Quality System Regulation
- ISO 9001, ISO 14971, additional standards
- European Standards – ISO 13485
- Quality & other function group synergy programs
Remediation
- Verification & Validation (Process & Development)
- FDA Warning Letter and 483 observations
- Risk Management Files
- DHF, DMR
- Notified body findings
- Mock Audits
Submissions
- 510(k) – Traditional, special, abbreviated
- PMA – Pre Market Approval
- CE Mark – EU
You need a team of focused quality and regulatory professionals, uniquely prepared for tackling today’s medical device company projects. We assemble “plug and play” teams that provide the exact skillsets you need to round out your staff.
Synergy is a beautiful thing.
Quality Systems from Scratch
Whether you’re looking to obtain ISO 13485/9001 certification or wanting to ensure compliance to 21 CFR 820, Medgineering™ provides the systems, document templates, high level strategy and streamlined roll-out that are important.
Medgineering™ and partners are experts in building a company’s Quality Management System (QMS) from scratch.
Remediation Expertise
Remediation is project-based “fixing” of company practices & procedures, products or strategic focus.
Remediation projects are unique in that they require individuals with knowledge bases different than traditional engineers; these specialists must be up to date on best practices, FDA Warning Letter and 483 observations and solutions and common industry practice mistakes. Furthermore, remediation methodology is a fast-paced, high impact strategy that requires quick integration into a company’s operating and quality framework without compromising time or money.
All of our projects begin with a thorough gap analysis and scope analysis to ensure accurate forecasting of budget and timelines.
Common remediation efforts that we have undertaken:
- Risk Management Files
- Process Verification and Validation
- Test Method Validation
- DHF
