F&D Group provides global medical device manufacturers with compliance consulting and training services to meet international regulatory requirements.

1. Compliance Consulting Services

(1) ISO 13485 Medical Device QMS Compliance Consulting

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

·       ISO 13485 & EU MDR/IVDR Compliance (System & Technical Documentation).

·       ISO 13485 & China GMP Compliance.

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

·       ISO 13485 & MDSAP Compliance (USA, Canada, Australia, Japan, Brazil).

·       ISO 13485 & Other National Regulations (e.g., TGA, PMDA, ANVISA).

·       Medical Device Supply Chain QMS (Supplier Audits & Compliance).

·       ISO 14971 Risk Management System Implementation.

·       ISO 62304 Medical Device Software Compliance Consulting.

(2) Medical Device Regulatory Compliance Consulting

·       EU MDR (2017/745) & IVDR (2017/746) Compliance

·       Conformity Assessment Pathways.

·       Technical Documentation Preparation.

·       Clinical Evaluation & Post-Market Surveillance (PMS).

·       Economic Operator Compliance Requirements.

·       Post-Market Modifications & Recertification.

·       UDI & EUDAMED Database Registration.

·       IVD Device Classification & Registration.

·       Performance Evaluation & Clinical Evidence Requirements.

·       Notified Body Audit Strategy.

(3) US FDA Compliance

·       FDA 510(k) Submission (for Class II Devices).

·       FDA PMA (Pre-Market Approval) Submission (for Class III Devices).

·       De Novo Submission Support (for novel Class II Devices).

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

·       FDA Establishment Registration & Device Listing.

·       FDA UDI Implementation.

·       FDA Inspection Readiness & Warning Letter Response.

(4) China NMPA Compliance

·       Medical Device Registration & Filing (Class I, II, III)

·       China GMP Compliance Consulting.

·       Clinical Trial Waiver, Filing & Registration Guidance.

·       Medical Device Adverse Event Reporting.

·       UDI Implementation & Traceability System Setup.

(5) Other Country-Specific Medical Device Regulatory Compliance: Compliance support for TGA (Australia), PMDA (Japan), ANVISA (Brazil), and more.

2. Training Services

(1) Medical Device QMS & Regulatory Training

·       EU MDR/IVDR Compliance Training.

·       ISO 13485 Training (Basic, Advanced & Internal Auditor Courses).

·       MDSAP Regulatory & Audit Training.

·       Technical File & Clinical Evaluation Report (CER) Training.

·       Post-Market Surveillance & Safety Reporting Training.

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

·       Medical Device Software Compliance (ISO 13485 + IEC 62304) Training.

·       ISO 14971 Risk Management Training.

·       Medical Device GMP Training (EU, China, USA).

(2) Medical Device Registration & Technical Documentation Training

·       CE Marking Technical Documentation Training.

·       FDA 510(k) Submission Training.

·       NMPA Medical Device Registration Training.

·       UDI Implementation & Global Regulatory Requirements Training.

(3) Medical Device Compliance Management & Audit Training

·       MDR/IVDR Notified Body Audit Preparation.

·       ISO 13485 & MDSAP Internal Auditor Training.

·       FDA QSR & Factory Inspection Readiness Training.

·       Supplier Audits & Quality Management Training.