Gregg Edwards; hold a BSEE from Worcester Polytechnic Institute. He has specialized in domestic and global regulatory strategies for medical devices and state of the art commercial products for the past 25 years. Gregg supports Manufacturers, R&D centers, scientists with a focus on product compliance, verification and validation methods to support essential requirements, and performance. Project work includes product approvals for FDA 510K, EU technical file support, product safety standards testing, and Japan Pharmaceutical Affairs law submission for medical devices.
Gregg started his regulatory background with third party product certification organizations providing testing services for information technology, industrial control systems, and medical devices. After the laboratory experience, he migrated into the commercial side of the business working as a hardware sustaining engineer for an optical networking technology company gaining valuable experience with detailed V&V, and debugging to component level.
Gregg later took on the role of independent consultant, which was later acquired by L3 Communications R&D group in Woburn, MA. There he directed regulatory activities for state of the art security and detection systems used for border and airport security, for which many of the systems are in wide use today, such as the RF body scanner.
Prior to Gregg’s most recent venture acquiring O’Brien Compliance Management, he held the position of Lead in regulatory activities at Mevion Medical Systems in Littleton, MA. Mevion developed and deployed the world’s first superconducting synchro-cyclotron particle accelerator for proton beam radiation therapy. Working with scientists, engineers, and subject matter experts Mevion successfully introduced two versions of the S250 device through regulatory approvals. Today both treatment modalities are in clinical use. Gregg’s involvement included successful planning and execution of EMC testing, and product standards approval. Including; development of test protocols for IEC 60601-1, EMC test plans along with essential performance requirements, test reports and plans utilized to support 510K, EU, and PMDA submissions for approvals. Gregg’s standards expertise includes national electrical code for large scale integration, of medical devices, 60601-1 general requirements, Light ion standard, 60601-2-64, X-ray and imaging standards, related IT/laboratory test and measurement equipment. He has further experience in risk management processes per IEC 14971, and QMS objectives utilizing methods within IEC 13485 guidance.
Debra Carlson; has a ABA from Dean College. She has held a variety of roles in business administration in the global regulatory compliance and product certification field for over 15 years. Recently, as VP of Operations for O’Brien Compliance Management LLC, Deb has been responsible for overseeing all company operations as well as project and staff management associated with customer fulfillment.
In her new role as Project Manager for Device Conformity and Testing, Deb’s goal is to ensure all projects run smoothly from inception to delivery. Her strong organizational skills including attention to detail and multitasking will help in establishing and maintaining relationships with our clients.
Deb’s prior experience has been 10 years as HR/Office manager for Curtis-Straus a Bureau Veritas Co along with 3 years as Director of HR Outsourcing for TBR Associates. Prior to that she has held varying positions in Office Management and HR with Inforonics and GenRad.