Our team of experienced consultants will work with you to develop a QMS that aligns with your business objectives and applicable regulatory requirements. We offer scalable QMS solutions for 21 CFR 820, ISO 9001, 21 CFR 1271, ISO 13485, and EU MDR 2017/745 compliance.
We understand that navigating compliance issues is a crucial part of running a successful medical device business. Our team successfully manages 483 warning letters, CAPAs, or non-conformances to adequately address quality concerns.
Auditing is necessary to ensure the appropriate quality control within your organization and among your suppliers. Our experts will help you create strong internal auditing and supplier quality management programs. Leave the internal and external auditing to our qualified auditors.
Our consultants are risk management experts. We'll help your business develop compliant risk management files that are valuable product development and change assessment tools.
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