Qserve Group is pleased to announce that Rishi Dewan has joined our team to further expand its capabilities in supporting the in vitro diagnostics and medical device industries worldwide.
Rishi has joined Qserve’s IVD Team, he is based in the United Kingdom and will be working closely with our Head of In-Vitro Diagnostics, Sue Spencer. Rishi’s core competencies include CE Marking Technical Files for MDD and IVDD, Gap Assessments to MDR and IVDR respectively. He has experience creating Quality Management Systems to ISO 13485 and is a trained Lead Auditor. Rishi also has experience with Software as a Medical Device (SaMD) working to IEC 60601, EN 62304 which are becoming increasingly important under the IVDR. Rishi also has extensive Market Access experience having worked in getting products to market in China, India, LATAM, APJ as well as Saudi Arabia.
Rishi’s recent experience includes implementing the regulatory challenges presented by BREXIT and was a Brexit SME for the MBD Division at Thermo Fisher Scientific. He holds a Master of Science in Drug, Discovery and Development and a Master of Pharmacy from the University of Sunderland. He also holds from Raaj Global Pharma Regulatory Affairs Consultants a Post Graduate Diploma of Regulatory Affairs, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs
About Qserve Group
Qserve’s mission is to support all medical device and in-vitro diagnostics manufacturers with a practical approach, translating existing regulations to understandable requirements. We serve to guide manufacturers in gaining and maintaining compliance as well as conducting clinical studies as a CRO to ensure safe and quality devices in the most streamlined way possible. Qserve’s global team combines its regulatory and clinical knowledge and experience in the medical device industry, sharing more than 900 years’ worth of combined expertise in the medical field. Having teams in the EU, USA, and China provides a global footprint for global regulatory, clinical, CRO and quality services.