February 10, 2021 -- AccuReg, Inc. is pleased to announce the appointment of three of the company’s long-time senior associates as Directors of Business Development. As their capacity of Acting Directors, Trudie Seeger, PhD, Alicia Rice, RAC-Devices, CQE, CSQE, CBA, and Dennis Henkelman, RAC, will be responsible for all aspects of business development at AccuReg, including expansion of the company’s global regulatory, compliance and clinical support programs.

 

Trudie Seeger holds a doctorate in experimental pathology with a research focus in immunology, and has over 35 years of diversified drug, biologics and medical device development and management experience. An AccuReg associate since 1998, she has extensive, successful experience in product development/clinical research strategies, regulatory submissions, and quality requirements/compliance in the US and all major international markets, including but not limited to the EU, Australia, Japan, Asia, India, Russia, Israel, UAE and Saudi Arabia.

 

Alicia Rice is an industrial engineer with over 30 years’ experience in quality, regulatory affairs, manufacturing, engineering and management in the medical device industry. An AccuReg associate since 1994, she has extensive experience as a lead auditor (QSR, EU-MDR, ISO Certified, MDSAP-TPECS Certified, supplier audits, and CRO EDC supplier audits) and is an industry-recognized expert in software and computer systems quality assurance and validation, and the design and implementation of CAPA and complaint-handling systems.

 

Dennis Henkelman is a Certified Regulatory Professional with over 35 years of experience in medical device and radiopharmaceutical submissions, compliance, FDA interaction and quality. An AccuReg associate since 2000, he is expert in the development and preparation of clinical and marketing approval/clearance submissions, implementation of Quality Systems compliance across multi-facility, multi-product manufacturing establishments, and successful client representation to the FDA and other regulatory authorities.

 

“Together, Trudie, Alicia and Dennis are a formidable team,” said Loui Silvestri, PhD, President/CEO of AccuReg. “Their combined skills and experience are immense. They have worked with us for decades and have gained the trust of our clients and staff. They know our clients well and understand their needs, and have firsthand knowledge of our personnel’s strengths and abilities. As Directors, they will lead our company to exceptional new levels of client support, due to their extensive understanding of the global regulatory market.”

 

“Many companies are striving to meet the regulatory deadlines established for 2021 and 2022 as a result of the EU Medical Device Regulations,” said Dr. Silvestri. “AccuReg is already working with many clients on these challenges.  Projects include updating technical documentation and Quality Management Systems to assist clients in successfully meeting their EU MDR/IVDR compliance objectives . With the promotion of Trudie, Alicia and Dennis to leadership positions, AccuReg is further expanding its resources in these and many other service areas, for the benefit of our clients world-wide.”

 

AccuReg takes great pride in detailed, hands-on customer service, based on a thorough understanding of each client’s products, culture, and particular circumstances. “We know that nothing can be accomplished on a long-term basis without building a genuine relationship with our client. When a client need is identified, it’s never sufficient to simply ‘send in a warm body,’” said Dr. Silvestri. “We are adamant about meeting each project’s requirements with the right resources for the job because we are going to stand by that work, each and every time. And we have decades of experience working efficiently and successfully from remote locations, striving to save clients on expenses whenever we can. This has always been our approach, and under the challenges we are all facing due to COVID-19 precautions, the ability to work effectively off-site is more valuable than ever.”

 

AccuReg, Inc., is a regulatory, compliance and technical consulting firm that has served the medical products industries world-wide since 1987, helping clients bring new products to market and achieve their compliance and quality goals. AccuReg’s wide range of services include regulatory applications and submissions; audits and gap assessments, including GxP, ISO, BIMO, MD-SAP and EU MDR; regulatory inspections readiness; and all aspects of QMS implementation. The company is known for its S4 Compliance Process (Simple, Systematic, Sustainable and Scaleable), developed in the field by Dr. Loui Silvestri and his team as a targeted, comprehensive compliance approach offering long-lasting solutions scaled to efficiently address root cause issues. AccuReg is a WBENC-Certified Women-Owned Business since 2006, and in 2020, gained additional certification from the Small Business Administration (SBA) as a Women-Owned Small Business (WOSB).

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AccuReg is based in South Florida but works with clients in the US and internationally.