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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.