Our services

From consulting and strategy development to implementation and support, our comprehensive services can help your business thrive.

INTERNAL AUDIT SUPPORT

Conduct audits to ensure compliance with regulations (ISO 13485, MDSAP, MDR), identify gaps, and receive actionable recommendations.

MDEL APPLICATIONS

Receive support for Health Canada MDEL submission process, including documentation preparation, & post-approval compliance support.

person holding pencil near laptop computer
person holding pencil near laptop computer
white concrete building under white sky during daytime
white concrete building under white sky during daytime
stack of papers
stack of papers
REGULATORY AFFAIRS

Navigate global regulations seamlessly with our expert guidance for FDA, EU MDR, and ISO compliance in the medical devices industry.

SUPPLY CHAIN OPTIMIZATION

Optimize your supply chain for reliability and cost-effectiveness in medical device production.

CONSULTATIONS

Reach out for expert advise on regulatory strategy, product development, or market entry.

a large cargo ship in the middle of a large body of water
a large cargo ship in the middle of a large body of water
person holding white disposable cup
person holding white disposable cup
brown and white box with silver frame eyeglasses
brown and white box with silver frame eyeglasses
LABELING AND PACKAGING COMPLIANCE

Navigate labeling and packaging regulations in the medical devices market.