WHO WE HELP
Design Evaluation: Compass assesses medical device designs for safety, efficacy, and compliance.
Risk Analysis: We identify potential hazards and recommend risk mitigation strategies.
Prototyping Guidance: We can provide 3D printed, anatomically correct models to support fit- and other bench testing before your design engineers proceed too far down the development path.
Quality Control: Compass evaluates manufacturing processes to ensure that your product is being made and tested according to your foundational requirements.
Product Design: Our team has decades of experience in research and development for medical devices and biologics.
Let us help you ideate your next product!
21CFR820 and ISO 13485 Compliance: Compass assists in creating and implementing quality management systems.
Audits and Gap Analysis: We can review your existing QMS and identify gaps in regulatory compliance. We can also help with internal audits to identify areas of nonconformance to mitigate findings in a formal audit or assist you with addressing unfavorable audit outcomes.
