Medical Device Development

Developing a medical device that can receive regulatory approval, reimbursement and market acceptance AND actually works AND can be built is no easy task. It's not just about the engineering. We have a 5 phased process, consistent with the FDA (21 CFR 820), the EU Medical Device Directive, and ISO 13485. The experienced staff at Corvax Solutions are here to help with part or all of your medical device development needs.

Planning

The right plan can save time and money later, setting up a company for success.

Because no one wants delays, increased cost, and reduced credibility with investors.

Design

Following and documenting the right process is critical for a reliable product and approval.

Because design is not just about the prototype.

Testing

It's important to know when the design works and the product is safe.

And, regulators expect Verification and Validation to be conducted in a certain way.

 

 

Manufacturing Transfer

Setting up manufacturing correctly ensures a quality product for the lowest cost.

Because not all manufacturers are right for every product and company.

Commercialization

Sales and follow-up product evaluation ensure continued success.

Because regulatory approvals and expanded marking are key.