Medical Device > Regulatory Compliance
Maetrics™ understands the microscope medical device manufacturers are put under when it comes to regulatory compliance. Here is a sampling of some of the initiatives that our collaborative team of industry thought-leaders is well-equipped to face:
- Regulatory strategy development
- Compliance audits, assessments, and gap analyses
- Supply chain audits
- FDA mock inspections for GMP, GLP, and GCP environments
- Warning letter remediation services
- CAPA handling and closure
- Preparation of responses to FDA 483, citations, and warning letters
- Audits for 21 CFR part 820 (QSR and QSIT audits)
- Computer systems audits and part 11 assessments and remediation
- FDA regulatory submission preparation/review
- Preparatory pre-approval inspection audits
- Implementation of quality and compliance based training procedures
If any of these regulatory issues are a pressing concern for you, or if you face an issue not listed above, contact the collaborative team at Maetrics™ for a complimentary assessment of your unique needs from a Lean Compliance point of view.
