Medical Product and Regulatory Affairs Consultancy  

Over 35+ Years of Experience in Medical Devices Manufacturing and Quality Assurance with 9 years in Medical Products and Regulatory Affairs Consulting services.

In the market place today, the development and marketing of medical products is a highly regulated process with strict governmental requirements of each country.  In China- CFDA, Philippines, Thailand, Taiwan FDAs and Australia - TGA, UK -MHRA and US -FDA are all regulatory bodies. Medipro Consultnacy is able to provide Regulatory   Affairs and Quality Assurance   consulting services to help medical device and in vitro diagnostic product manufacturers to meet those requirements.

By leveraging Medipro's comprehensive knowledge of CFDA, CE - MDR and IVDR, ISO international regulations and standards ISO13485:2016, ISO14971:2012, ISO10993:2018. We can help capture and grow your market share, increase productivity, and stay competitive in an increasingly complex challenging marketplace. 

We can help your team to prepare for a regulatory body, CE, ISO 13485 or any regulatory body audit, or ensure ongoing compliance, Medipro has the experience and knowledge to lead you to success.

Services provided:

ISO13485 QMS and GDPMDS setup. Training on ISO13485:2016 QMS, IQA, Awareness, Implementation, Clause by Clause GDPMDS, GMP, 21CFR Parts 820, 821, 803, Part 11, ISO10993 Medical Devices Biocompatibility and Medical Devices Design Development control, Process Validation and Different Methods of Sterilization(ETO, Gamma and Steam) Trainer at BSI Singapore, TUV-SUD, Malaysian Dreamcatcher Sdn. Bhd., Indonesia ASAPKI and GAKESLAB.

Work with all the Regulatory Bodies in the ASEAN region to register clientele’s products in the region and liaises with them for all regulatory affairs issues. The ASEAN authorities are Local H.S.A., Malaysia MDA, Indonesia NA-DFC, Vietnam DAV, Philippines, Taiwan, and Thailand F.D.As. Others: China CFDA, Russia MOH, Canada HC, US FDA for 510K and PMA, European EC for CE Mark, Australia TGA, UK MHRA, and Japan PMDA/M.H.L.W.    

Regulatory Affairs Consultant for a US Animal Tissue products company, with their plant in Perth, Australia using Bovine Pericardium for Heart Valve and Vascular Tissues for 18 countries in the Asia Pacific, Middle East, North Asia, and South American countries.  

We can also introduce your company to promising medical devices or equipment currently in the regional market for distribtuion and the same time able to help negotiate for a Joint Co-operation or development of medical products together.

We can also act as a liasion partner for merger and acquistion of potential companies for takeover. We help to identify the medical product niche for our clients.  

We can also provide raw materials recommendation, selection, medical components and final medical product recommendations for medical use.

With our wide regional experience, we can also offer special consultancy services in the area of manufacturing process improvements. These can be related to productivity improvements, yield improvements, and product development improvements, and also business process improvement.