Aligning your Quality System with ISO 13485:2016 can be challenging. With 10 years of experience in electronic Quality Management Systems (QMS), Mina Methods is a valuable resource for you and your team.

Need assistance with medical device regulations? We can help write and review 510k submissions, Q-Sub requests, Technical Documentation (MDR), and other regulatory filings.

Our expertise in Post-Market Surveillance Documentation (CEP, CER, PMCF, PSUR, SSCP) ensures your products remain compliant and successful in the market, providing ongoing regulatory support throughout your device’s lifecycle.