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Our team of consultants bring years of experience from within quality assurance and regulatory affairs management positions at medical device companies, as well as medical device lead auditors for notified bodies. This combination of hands-on experience and in-depth knowledge of regulatory requirements allows us to deliver efficient and effective solutions to our clients. Our team is dedicated to ensuring competence, conformance, and compliance with all regulatory and statutory requirements.

Our mission is to empower medical device companies to deliver safe and effective solutions to patients. By offering a range of consultancy services and cutting-edge training programs, we aim to raise the bar on quality, safety, and competence in the medical device industry. Our focus is always on patient safety and ensuring our clients are confident in their ability to navigate the ever-changing regulatory landscape.