We provide a comprehensive portfolio of quality and Audit services, including:
- Quality System Audits and Gap Assessments
- Mock FDA Inspections, MDSAP, CE Mark, and ISO Audits
- FDA 483, Warning Letter, Consent Decree, and ISO Observation Response
- Tech File / Dossier Audits
- Supplier Audits
- Remediation Planning and Support
Auditing
On-site and remote auditing services. Or a hybrid combination if on-site time is necessary, but you opt to keep it limited. We perform gap assessments and audits to assist manufacturers like you in meeting auditing commitments and identifying any compliance gaps between your systems and the constantly changing international regulatory requirements. We ensure that any changes are assessed for their impact on both your quality system and your devices.
Remediation Services
Did an internal audit uncover significant system gaps? Did an FDA investigator or ISO auditor find significant non-compliances? Our highly experienced remediation teams work hand-in-hand with your employees to uncover the root cause of these issues, develop practical, effective, and cost-efficient solutions, and implement the necessary measures to bring your systems into compliance to safeguard brand reputation for quality products now and in the future.
We’re here to help
Handled several Audits for Medical Device manufacturers doing Tech file / Dossier. QMS, Process, CRO, and Vendor audits