We start with your part and tool design to ensure the product will be optimized for manufacturability (DFM) and meet all the intended use and user needs. We can help with material selection and biocompatibility.

We support your Design Controls requirements, and can help build DHF, DMR, and RMF to support 510(k) submissions

Our experienced engineers use the latest technology to design injection molds that meet the highest industry standards. We work with our clients to optimize their designs for manufacturability, ensuring the highest quality results.

We have FDA cGMP expertise and can help your team navigate the regulatory process for Design Controls, Risk Management, and Validation.

Our team knows how to structure your Master Validation Plan (MVP) with a risk-based approach that won't leave you buried in documentation. We have attended FDA training and defended our protocols and reports in FDA Inspections. Ask about our depth of knowledge in: 

IQ

OQ/OQ-E

PQ

We can provide low to mid-volume production injection molding, with the capacity to ramp up to  millions of parts per year. Our advanced equipment and experienced medical molding team ensure consistent quality and on-time delivery.

Value add, secondary operations, managed packaging validation, managed Ethylene Oxide (EtO) and Gamma sterilization validations programs