Nerac Adds Skilled Professionals to its Medical Device Practice Group
Zamir Bar-David and Michelangelo Malleo bring over 50 years combined experience in the healthcare and medical device industry
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.
Zamir Bar-David brings more than 25 years of experience in regulatory, compliance and quality management in medical devices, pharmaceuticals, IVDs, labs and CROs. Most recently, he was the Lead Auditor and Trainer for Intertek Business Assurance where he was responsible for assessing and auditing client's quality and regulatory systems to the latest requirements, as well as training clients on international standards, regulations and auditing programs. Previously he worked for TUV Rhineland as a lead auditor, Stryker Orthopaedics Corp. as a Regulatory Affairs Consultant, Hydrocision, Inc. as a QA/RA Manager and Waters Corp. as a Quality Systems Lead Auditor.
Michelangelo Malleo has more than 25 years experience in medical devices and biotech pharmacological product sales. He was instrumental in bringing several companies to the commercialization phase, such as Abbvie, Scios Inc. and COR Therapeutics. His vast surgical experience with medical devices such as pacemakers, capital equipment, pumps and pharmacological compounds etc provides him with a wealth of expertise in the medical device marketplace.
"We are excited to welcome Zamir and Michelangelo to our medical device team," said Dennis DeCesare, Vice President of Business Development and Advisory Services at Nerac. "Their experience and expertise further enhances our ability to deliver services that ensure compliance and successful notified body audits with reduced risk and minimal business interruption, and to provide all those services from a reliable source."
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.