About Us
Gregg Edwards holds 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 30 years, supporting Manufactures, R&D centers as well as scientists with a focus on product compliance and verification methods to support essential requirements and performance.
Gregg’s 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.
His 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 to IT/Laboratory test and measurement equipment, IEC 14971 risk management process and QMS objectives utilizing methods within IEC 13485 guidance.
Gregg’s regulatory journey began with third party product certification organizations providing testing services for IT, Industrial control systems and medical devices. He then migrated into the commercial side business working as a hardware sustaining engineer where he gained valuable experience with detailed V&V and debugging to the component level. Here is where he started to direct the regulatory activities for state of the art security and detection systems such as the RF body scanner which are in wide use today.
He then moved on to be Lead in regulatory activities at Mevion Medical Systems. Where his involvement encompassed the successful planning and execution of EMC testing, and product standards approval. Including the development of test protocols for IEC 60601-1, EMC test planning along with essential performance requirements test reports and plans utilized to support 510K, EU and PMDA submissions for approvals for the world’s first compact proton beam radiation therapy system.
With his most recent venture acquiring O’Brien Compliance Management back in 2018, Gregg is able to continue his many years in the compliance field and carry the safety mission forward.
William Bollas holds an AAS degree from Alfred State College – SUNY College of Technology and is an iNARTE Certified Product Safety Engineer.
Bill comes to us from UL where through his 31 year career has worked in many engineering roles. Starting as a Project Engineer Bill assisted a team in the transition from national safety standard products evaluations to international standard product evaluations where he handled product safety evaluations for ITE, Medical, Laboratory and Commercial Audio products.
He then moved to Germany for 6 years to manage the UL Munich, Germany office training local staff in conducting evaluations on ITE, Medical and Laboratory equipment to appropriate UL Standards 2601, 60950 and 61010.
After his 6 years managing the office and training in Germany, Bill moved to Toronto, Canada where he was the Assistant Director of the Electrical Division as onsite technical expert for IEC 60950; he was instrumental in UL Canada becoming an IEC CB Scheme NCB.
Following his 3 year assignment in Toronto, Bill moved back to the States where he worked in the Melville, NY office as a Customer Service Technical Specialist and then as Lead Engineering Associate where he was responsible for handling one of UL’s major customer accounts for ITE and Audio/Video over seeing witness testing and technical reviews, while mentoring and training staff.
Bill then worked for 5 years in the Life Safety and Security group, managing projects involving product evaluations to UL 864 (Control Units and Accessories for Fire Alarm Systems), UL 1023 (Household Burglar Alarm Systems) and UL 294 (Access Control Systems).
Bill joined O’Brien Compliance Management in 2014 as a Sr. Engineer working with Medical Device companies to navigate through the IEC 60601-1 process. When OBCM was sold to Device Conformity and Testing in 2018 he joined DC&T as Technical Manager, responsible for developing, reviewing, and maintaining test procedures, providing technical training for staff as well as the evaluation and testing of Medical Equipment and Laboratory Equipment. His expertise and vast UL and international experience with the IEC 60601-1 and IEC 61010-1 standards allows DC&T to help its customers get their products to market faster and safer.
Deb Carlson holds an AS in Business from Dean College.
Deb comes to us with 25+ years’ experience in Customer service, Client relations, Project management and Contract negotiations. She has held various roles in the Lab Testing environment, from HR to Facility management to Project Management to VP.
She started her Lab career at Curtis Straus as the HR/Office Manager where she successfully built up the CS engineering team, as well as instituting new policies and negotiating new benefits packages for the company. The Company was later bought by Bureau Veritas and Deb along with the Engineering Manager took on the project of building out and moving the existing 10,000 sq. ft. facility to a new 60,000 sq. ft. facility, where once completed she took on the role of facilities manager.
A few years later, she left BV to start her own HR consulting firm. After a successful 2 year run the company merged with TBR Associates in order to gain a larger market share and Deb moved into the role of Director of HR outsourcing. Not enjoying the daily travel all over the state, she returned to the Lab environment joining O’Brien Compliance Management to help them with some HR/admin as well as sales and marketing work. There Deb found her niche in the sales, marketing and project management piece of the company. When the company founder decided to retire and move to Ireland in 2018 the company was sold to Gregg Edwards who started Device Conformity and Testing, where Deb continued to work in a PM role for about a year before taking a huge gamble opening a wine bar in March of 2020. After 4 years of enduring Covid, a recession and the new mock-tail generation the bar closed and Deb is now back with Device Conformity and also has a fantastic wine cellar.
Consulting
We can help with all aspects of safety compliance and be your go to expert for issues that may arise.
Field Evaluations
We can provide field labeling and evaluation services to secure approval from local inspectors and quickly get your products in compliance.
Semi S2
Consider us to help with your equipment evaluations.
IEC 60601-1
We offer full 60601-1 testing and consulting services as well as tailored testing of your product when you need to evaluate early on in the product development process.
IEC 61010-1 Testing
We offer 1010 testing services for Measurement control and Laboratory equipment. Call or email for a quote!
EMC Partnership Testing
We partner with local EMC labs to provide you with a comprehensive "one-stop shop" for all your testing and certification needs.
510K submission, MDR and Regulatory Guidance
We will guide you through the 510(k) submission process and the MDR regulatory guidance reporting with speed and efficiency in order to keep time and cost to market at a minimum. We have extensive experience working directly with the FDA and its reviewers, and can provide you with in-depth product knowledge and industry expertise throughout your submission review.
EU Machinery & Low Voltage Directives
With our expert guidance we provide compliance services for machinery directive 2006/42/EC, which also contains requirements for risk analysis where we can assure you that your product will receive the highest level of evaluation and the safest design.