Guiding you through compliance complexities with expertise and precision.

Martin Quality Consulting specializes in navigating the intricate landscape of regulatory compliance, ensuring your medical devices meet FDA and international standards with confidence and clarity. Our comprehensive services include:

• Regulatory Strategy Development: Crafting tailored regulatory strategies to align with business goals, product roadmaps, and global markets.

• Gap Analysis: Identifying areas of non-compliance and providing actionable recommendations to reduce business risks.

• Audit Preparation and Support: Assisting with audit readiness and preparation for notified body and FDA inspections.

• Training and Workshops: Offering customized training programs on regulatory requirements and best practices.

Areas of Expertise:

• ISO 13485: Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes

• 21 CFR Part 820: FDA Quality System Regulation & Quality Management System Regulation (QMSR)

• 21 CFR Part 11: Electronic Records and Electronic Signatures

• EU Medical Device Regulation (MDR) 2017/745

• EU In Vitro Diagnostic Regulation (IVDR) 2017/746

• MDSAP: Medical Device Single Audit Program