Nerac continues to expand its Medical Device Practice Group
Robert Zott brings over 20 years experience in regulatory affairs and quality compliance
Nerac is pleased to announce the addition of Senior Regulatory Professional, Robert Zott to its medical device practice group. The addition comes as Nerac continues to expand their services and capabilities to ensure medical device and in-vitro diagnostic device companies are prepared for the upcoming regulatory, quality and clinical changes.
Medical and diagnostic device products currently on the market now or releasing in the future face significant regulatory changes that will impact business significantly. The substantial changes which include the recently released Clinical Evaluation Report MEDDEV Rev 4, the highly anticipated Medical Device Regulations (MDR) and In-Vitro Diagnostic Medical Device Regulations (IVDR), along with the Quality Management System ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP), are among a number of initiatives undertaken by the US, EU and other global regulatory bodies. Companies that market products requiring global compliance need to be aware and prepare for the significant regulatory, clinical, and quality changes upon them now, and on the horizon.
Robert Zott brings more the 20 years of experience in regulatory affairs and quality compliance to Nerac. As a Senior Regulatory Professional for Nerac, he will be supporting medical device companies with developing clinical evaluation reports, quality planning, corrective and preventive action plans and standard operating procedures to meet their compliance requirements. As Program Director for Technology Development at Covidien Surgical Devices, he was responsible for the strategic development and submissions authorship for soft tissue implants and advanced laparoscopic instruments. At Underwriters Laboratories, he contributed to the development and accreditation of the UL ISO 9000 Registration Program. As a BSI-certified lead auditor, he conducted pre-assessment audits and consulted on topics ranging from CE-marking to biomedical investment, and he has lectured extensively on regulatory and quality compliance to organizations ranging from local ASQ chapters to the U.S. Department of Commerce.
"We are excited to welcome Robert to our medical device team," said Dennis DeCesare, Vice President of Business Development and Advisory Services at Nerac. "He brings a wealth of knowledge and experience in regulatory affairs and quality compliance that will quickly serve to streamline regulatory and quality compliance processes for our client base."
Learn more about our regulatory expertise and medical device services here (https://www.nerac.com/
Nerac Inc. is a global research and advisory firm for companies developing innovative products and technologies. Nerac provides expert insights that equip clients with the knowledge to develop or refine a technology, explore market growth opportunities, evaluate intellectual property strategies and respond to medical device regulatory compliance challenges. Nerac serves approximately 5,000 users worldwide and delivers over 12,000 research projects and custom alerts each year. Nerac has a long, successful consulting history in a wide-range of industries with significant expertise and extensive data resources supporting client requests in the areas of technology scouting, IP, medical device, engineering, chemistry and advanced materials.