Manufacturer’s Challenges: Mastering EU MDR and IVDR Compliance

Sushil is a seasoned strategist with five (05+) years of experience in Medical Device, Healthcare, and FMCG sectors. He holds a BE and MBA from BITSoM and is certified in ISO 13485 audit and Lean Six Sigma Green Belt from TUM Munich. He is proficient in Go-to-Market strategies, key account management, and team building. He excels in assisting clients to enter new markets and offers comprehensive Regulatory solutions, developing customized strategies that enhance organizational value.

Sravanthi Mingi, with ten (10+) years of experience in Regulatory affairs, possesses extensive knowledge across various categories of medical devices. With a master’s degree in Biomedicine from Orebro University, Sravanthi leads Europe consulting, primarily focusing on the CE certification and aiding medical device manufacturers in complying with the EU MDR/IVDR. She is recognized as an expert in medical device regulations and has assisted both start-ups and multinational corporations in developing product strategies for the EU market. Her core area of expertise involves developing Regulatory strategies during device development, submission strategies, and overseeing Regulatory submissions throughout the approval process.

Dr. Ceren Alemdaroglu, PhD, with fifteen (15+) years of expertise in pharmaceutical and medical devices industry has focus on the EU MDR, EU IVDR, Swiss MedDo & IvDO. She serves as a Person Responsible for Regulatory Compliance (PRRC) and is responsible for Authorized Representative services (EAR, Swiss AR).

Ceren specializes in Regulatory affairs of medical devices and in vitro diagnostics including technical documentation, as well as Quality Management Systems (QMS) for both sectors. Her extensive background includes guiding companies through Regulatory processes and ensuring compliance with stringent standards.