With our decades of expertise in life science consulting, JOOVIS Team works collaboratively with clients to guide quality management strategies. We can support you with all questions and challenges concerning quality management worldwide.

JOOVIS B.V. gladly supports you in:

• Implementation of a complete quality management system in accordance with the requirements of ISO 13485:2016 and ISO 9001:2015
• Assessment of your QMS with regard to regulatory and normative requirements (e.g. ISO 13485:2016, 21 CFR 820 Quality System Regulation, Medical Device Single Audit Program (MDSAP), ANVISA: RDC 16/2013
• Conduct of internal audits and supplier audits
• Training and further education of your quality management representative
• Preparation, support and follow-up of inspections and audits
• Complaints, Corrective Action/Preventive Action (CAPA), Adverse Event (AE), Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) processes and systems