Testimonials

Design Control Services

We have the knowledge and expertise required to guide the controlled introduction of new product, from initial concept through to design transfer and commercial manufacture

Services

Design and Development Planning
Design History File Compilation
Risk Management Planning
Design Trace Matrix Compilation
Biocompatibility considerations
Design Inputs collation
Design Outputs review
Design Verification– testing strategies for:
- Transit testing
- Biological evaluation
- Electrical safety and performance testing (IEC 60601, IEC 61010)
Stability studies
Design Validation:
- Usability Studies
- Clinical investigations
Design transfer into Manufacturing
- Initial Manufacturing set-up and IQOQPQ
- Process validation

Quality Services

We work across all aspects of the Quality Management System (QMS) through every phase of the device lifecycle

Quality System Writing

Clients require compliant and pragmatic internal instructions that meet external regulations and applicable standards and support the consistent manufacture of safe and effective product. Instructions must be operationally viable and personnel must be able to consistently follow all internal instruction and generate records to evidence that those internal requirements have been consistently met.

OAKA Medserve consultants have a vast experience in this area, both;

- Designing brand new (v1) QMS's for start up businesses

- Reworking established QMS processes for large corporate clients

Other Quality Services