life science product design, development, and production

industry best practices

risk management


Design verification and validation, risk management reports, design history files, regulatory strategy appropriate for the intended use.

Strict compliance with FDA and CE quality system requirements, with full documentation to support your market entry. 

Product design, prototyping, material selection, design review. We'll provide the steps to get your ideas ready for the market.​


strategic planning

Production planning, lot history records, first articles, process validation, sterility, packaging, and shipping of your products to your customers.