Our Go to Market Services encompass the expertise to effectively move an approved medical device design through manufacturing development to regulatory approval and introduction. The services we offer are:
To find out more contact us today.
Our manufacturing engineering capabilities helps clients to correctly produce the manufacturing system and technologies needed to make a new or improved medical device to requirements. We offer expertise in:
Design for Manufacture
Supply Chain Sourcing
Implementing New Technologies
Transfer to Operations
Our expertise and experience in Quality management and techniques and Regulatory Affairs is accredited by the UK Chartered Quality Institute.
We will help ensure clients achieve safe and trustworthy medical devices and manufacturing capabilities that meet the FDA and ISO 13485 Medical Device Design Quality and Regulatory compliance requirements.
Areas we can help clients with include:
Regulatory Approval Strategy
Developing Design Briefs
Design History Files and Documentation
Design of Experiments
Verification and Validation
Obtaining CE Marking and FDA Approvals
Contact us today to tell us what your quality and regulatory needs are.
Our product brand design services will help successfully improve the perceived value, usability, and promotion of clients new or improved medical device. Our range of brand design services includes
Product Packaging Design
Product Launch Visual Materials
To learn more contact us today.