F&D Group provides certification, consulting, and training services for global medical device manufacturers to ensure compliance with ISO 13485 and related regulatory requirements.

1. Certification Services

·       ISO 13485 Certification: Global standard for medical device QMS.

·       ISO 13485 Surveillance & Recertification Audits.

·       ISO 13485 + EU MDR/IVDR Compliance Audits: Required for CE marking of medical devices.

·       ISO 13485 + China GMP Compliance Audits.

·       ISO 13485 + FDA QSR (21 CFR Part 820) Compliance Audits.

·       ISO 13485 + MDSAP Integrated Certification: Meets requirements for the US, Canada, Australia, Japan, and Brazil.

·       ISO 13485 + Other Country-Specific Compliance Audits (e.g., TGA, PMDA, ANVISA).

·       Supplier Audits & Second-Party Audits.

2. Consulting Services

·       ISO 13485 QMS Implementation & Documentation Support (Quality Manual, Procedures, Work Instructions).

·       ISO 13485 Compliance Gap Analysis & Corrective Action Plan.

·       Regulatory Integration Consulting: Combining ISO 13485 with MDR, IVDR, FDA QSR, MDSAP, etc.

·       ISO 13485 & ISO 14971 Risk Management System Integration.

·       ISO 13485 & IEC 62304 Compliance for Medical Device Software.

·       Supplier QMS Optimization & Quality Control.

·       Internal Audit Guidance & Corrective Action Support.

3. Training Services

·       ISO 13485 QMS Implementation Training (Basic & Advanced).

·       ISO 14971 Risk Management Training: Identifying & mitigating medical device risks.

·       ISO 13485 Internal Auditor Training: For in-house compliance professionals.

·       Design Control & Documentation Management Training.

·       ISO 13485 Lead Auditor Training (for those pursuing auditor roles).

·       ISO 13485 & EU MDR/IVDR Compliance Training: Covers conformity assessment, technical file preparation, UDI registration.

·       ISO 13485 & FDA QSR (21 CFR Part 820) Compliance Training.

·       ISO 13485 & IEC 62304 Medical Device Software Lifecycle Training.