QUALITY MANAGEMENT

• Quality Management System (QMS) – ISO 13485, ISO 9001

• Outsourced Quality Manager

• Person Responsible for Regulatory Compliance (PRRC)

• Auditing for Quality Management Systems & Technical Files

• Equipment Qualification

TECHNICAL FILE

• Medical Device Technical File – Design History File (DHF)

• Design Control, Usability

• Risk Management (ISO14971)

• Clinical Evaluation under the EU MDR 2017/745

• Biological Evaluation under the EU MDR 2017/745

• Our Global Reach (EU MDR, US FDA, JP, CMDCAS)

CONSULTING

• Quality Assurance (QA) & Regulatory (RA) Compliance Consulting

• CMO & Supplier Management

• Industrial Sterilisation of Medical Devices (EO, Gamma, E-beam, X-ray)

• Distributor Management

• Business Development

STERILISATION PROJECTS

We deliver highly systematic and detailed approach to your sterilisation projects (EO, Gamma, E-beam, X-ray).

Explore our services.

REGULATORY CHALLENGES

Would you like to understand the possibilities and challenges getting a new MedTech innovation from the idea to market launch?

We can guide you.

COURSES AND TRAINING - ACADEMY

​We offer tailor-made courses for your organization in QA/RA and sterilization. We can train both individuals and groups.

Explore our courses here.