Capamed audits quality systems according to ISO 13485, MDR, and FDA QSR (21 CFR 820). We will provide you with an overview of the audited area’s compliance as well as specific instructions on how to resolve any differences.
We conduct our audits in accordance with the requirements of the FDA or appropriate European authority. All audits are conducted by a certified auditors.
- Gap Analysis Audit: Detection of vulnerabilities and deviations
- Pre-inspection Audit: Preparation for an external inspection (FDA, Notified Body)
- Outsourcing of Internal Audits: By staff shortages and coaching of internal auditors
- Vendor Audit: Qualification and monitoring of suppliers, contract manufacturers, etc.
- Compliance Audit: Verification of compliance; documentation requirements for products; change(s) in regulatory requirements, etc.