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Experience & Professionalism

We understand that there are many different requirements for  working in the medical device industry. That is why we have experts who specialize not only in the assessment, evaluation, and documentation against applicable requirements but also in their  implementation.

Our team comes from years of experience both  inside QA/RA management positions at companies like yours, and  as Medical Device Lead Auditors for Notified Bodies who in  addition have successfully trained professionals in various roles on  the most efficient and effective ways to ensure competence, conformance, and compliance to regulatory and statutory requirements.

At South Star Consultants, we offer a wide range of services to help your company succeed in the medical device industry. Our consultants have 10 or more years of hands-on  experience, with at least 5 as a Medical Device Lead Auditor for  Notified Bodies, as well as extensive project management  experience from inception through completion.

Your experienced  South Star Consultants is certified against applicable standards and  regulations, and we proudly provide their certification and credentials upon request. We have the knowledge and expertise you  need to create a Quality Management System that will meet or  exceed industry standards.

We help you meet these standards through assessment, remediation and implementation services that  will allow your organization to stay up-to date with statutory and  regulatory changes. Our deep understanding of the requirements for managing medical devices combined with South Star Consultants  unique perspective informed by years of experience as Engineers,  Lead Auditors and Certified Trainers for Notified Bodies, Consultants, and former members of industry has established South Star Consultants as a global leader in regulatory training and  consulting services.

South Star Consultants is well-versed in  industry specific state-of-the-art standards and regulations of the  medical device quality management system (QMS) to include but not limited to IMDR -2017,ISO 3834, ISO 9001, ISO 13485, ISO 14971, ISO 3834, ISO 45001,ISO 14001, ISO 17025, ISO 21001, ISO  22000, ISO 27001, SA 8000, IATF 16949, ISO 50000, IS0 55001,  AS 9100, TRADE MARKING,WRAP, SMETA (SEDEX) , CE  MARKING AND THIRD PARTY INSPECTION.