quality-compliance-consulting | Access-2-Healthcare

Maintaining Your Organisational Agility

Quality System and Risk Management Consulting

Quality is the Bedrock of Any Medical Device Organisation

We provide Made-to-Measure Quality Consulting solutions, establishing the quality management system from scratch. No cookie-cutter solutions! We take the time to understand your organisation, on- or off-site, providing a scope of work that is tailored to your exact needs.

Seamless Risk Integration

We assist in establishing the risk management feedback loop with your design and ensuring the risk controls translate to the necessary design changes.

QUALITY IS THE BEDROCK OF ANY MEDICAL DEVICE ORGANISATION

Assembling a new quality management system from scratch is our specialty. No cookie-cutter solutions! We take the time to learn about your company, on or off-site, and customise our services to your specific requirements. We also help bigger organizations manufacture and smaller companies outsource manufacture. We convert non-medical QMS to medical and fill holes in current systems.

Also, Access-2-Healthcare was part of the TC210 teams actively developing and writing ISO13485 and ISO14971 standards, and has extensive expertise in medical technology production and commercial situations.

Learn more about ISO13485 and ISO14971

QUALITY SOLUTIONS THAT SOLVES VARIOUS QUALITY CHALLENGES

QUALITY MANAGEMENT SYSTEM

GAP ANALYSIS & REMEDIATION

COMPETENCE DEVELOPMENT & INSPECTION

What sets us apart?

REAL-WORLD CONNECTIONS

Access-2-Healthcare has connections with different types of investors, all with healthcare and/or MedTech mandates. We understand each investor’s needs well and can tap on a large database of MedTech companies, a list we have accumulated over years of good relationships with founders and CEOs.