ISO 9001 & ISO 13485

ISO Consulting for Medical Devices & Biotech

I provide expert consultation for ISO 9001 (Quality Management Systems) and ISO 13485 (Medical Devices QMS) implementation and auditing. Whether you're a medical device company seeking initial certification or an established biotech looking to improve your existing quality system, I offer practical, tailored solutions.

ISO 13485 is the essential standard for organisations involved in the design, production, installation, and servicing of medical devices. It demonstrates your commitment to quality and is often a prerequisite for market access, particularly in the EU (CE marking) and US (FDA).

What I Offer

• ISO 9001 QMS implementation
• ISO 13485 QMS implementation for medical devices
• Gap assessments and remediation planning
• Pre-certification audits
• Internal audits
• Process optimization
• Documentation development
• ISO training for staff
• MDSAP (Medical Device Single Audit Program) support

ISO 9001 vs ISO 13485

ISO 9001 is a generic quality management standard applicable to any organisation. It's the world's most widely used quality standard and demonstrates your commitment to quality and customer satisfaction.

ISO 13485 is specifically designed for medical device companies. It incorporates additional requirements specific to medical devices, including traceability, risk management, regulatory compliance, and validation activities. If you supply medical devices, ISO 13485 is typically required.

Why ISO Certification Matters

• Market access - Many customers require ISO certification as a supplier prerequisite
• Regulatory compliance - Essential for CE marking and FDA clearance
• Competitive advantage - Stand out from uncertified competitors
• Risk reduction - Systematic approach to quality reduces errors and recalls
• Continuous improvement - Framework for ongoing efficiency gains
• Customer confidence - Demonstrates commitment to quality

Who I Work With

I work with medical device companies of all sizes, from start-ups seeking initial certification to established companies looking to improve or maintain their quality systems. I also support biotechnology firms, IVD (In Vitro Diagnostic) companies, and contract manufacturers.