Medical devices

EXPERIENCE THAT MATTERS

We are a strong team with long experience covering quality and regulatory management for medical devices. The team has experience from companies such as small start-ups in more generalist roles to large corporations where specific knowledge is key covering fields e.g. dentistry, ventilation, x-ray, software, and combination products.

SERVICES

Quality Strategies and projects
QMS management, construction, implementation, and maintenance.
GMP/GDP/ISO13485.
Audits- GMP/GDP/ ISO13485/MDSAP
Risk assessments, ISO 14971.
GAP-analysis and CAPA plans
Audits- internal, supplier, joint audits, mock-audits
Inspections- preparations before inspections from authorities
Risk assessments, ISO 14971
GAP-analysis and CAPA plans
CAPA management
Life cycle management, e.g. change control, PMS, complaints, deviations

Services

Quality agreements
Training programs, GMP/GDP/ ISO13485
Regulatory Affairs Market access and registrations
MDR, MDD
GSPR
IEC 60601 family
CE-marking – Identify applicable requirements and standards early in the development process
Support with the technical documentation and the classification of the device
Notified body submission support
Authority contact and support
IVDR
Training

We can also provide other services, please contact us for a discussion on how we can help you.

Team & Contact