Your Trusted Medical Device Quality and Regulatory Partner
"The team with the best players wins!"
Jack Welch
Your Trusted Medical Device Quality and Regulatory Partner
"The team with the best players wins!"
Jack Welch
Who We Are
Device QR Services, Inc. is a full service Quality System and Regulatory Affairs consulting company serving the medical device industry.
Quality System Services
An effectively designed and implemented Quality Management System will not only save you time and money in the long run, but also will optimize your manufacturing efficiency and regulatory compliance. Device QR Services, Inc. specializes in setting up and implementing bullet proof Quality Systems.
We can assist with:
- Performing gap assessment of the current QMS system to the requirements of ISO 13485, FDA QSR and Europe MDR.
- Designing and implementation of the quality system that meets 21 CFR 820, ISO 9001 and ISO 13485 requirements.
- Helping companies to achieve ISO13485:2016 certification.
- Reviewing and/or preparing QA system and related documentation.
- Conducting Quality System, Supplier and Due Diligence audits.
- Developing and maintaining supplier qualification program.
- Incorporating statistical sampling plans (e.g. C=0, ANSI Z1.4)
- Developing and implementation of the effective CAPA, internal non-conformance and complaints processes.
- Risk Management
- Training and couching of personnel - including ISO 13485, FDA QSR (cGMP), Europe MDR
- Assisting to apply for and implement Government grants to achieve your KPI goals.
Regulatory Services
- CE Marking
- 510(k) Premarket Notification Submission
- Regulatory strategy development
- GMP/QSR Compliance to 21 CFR 820
About Us
Testimonials
Testimonials
Device QR Services, Inc. was founded by Natalya Koshnitsky in 2020 after 17 years of Quality Assurance, Quality Systems and Regulatory Affairs experience within the Medical Device Industry.
In her most recent role Natalya Koshnitsky has served as the Director of Quality Systems and Regulatory Affairs where she successfully designed and im
Device QR Services, Inc. was founded by Natalya Koshnitsky in 2020 after 17 years of Quality Assurance, Quality Systems and Regulatory Affairs experience within the Medical Device Industry.
In her most recent role Natalya Koshnitsky has served as the Director of Quality Systems and Regulatory Affairs where she successfully designed and implemented a global quality management system and obtained an umbrella ISO 13485 certification for three facilities in the US and Central America. She is highly experienced in all areas of quality management system and compliance, including but not limited to CAPA, Internal non-conformance, internal and supplier auditing, supplier control and post market surveillance.
By working with her regulatory partners, Natalya has successfully commercialized medical device products in over 42 countries worldwide, including CE Marking and 510(K) clearance.
Natalya is an authentic leader with a natural ability to connect with various stakeholders of the organization to reach the set objectives and drive business forward.
Having passion for continuous learning, Natalya first moved to Brussels, Belgium, where she lived for four years and achieved her Bachelor of Arts degree in Communication with minor in Business from Vesalius College, graduated with Cum Laude and Best Honor Thesis Award.
Presently, she is a proud resident of one of the Boston areas in Massachusetts. She holds a Master of Science degree in Health Product Regulation from Regis College and the Program for Leadership Development (PLD28) Certificate from Harvard Business School.
Testimonials
Testimonials
Testimonials
" Natalya in a few words or phrases: resilient, focused, insatiable desire to learn, and receive feedback better than anyone. More specifically, Natalya helped navigate and transform our company into a medical device coating company through her intense focus and determination to obtain ISO13485 certification. In the process, we became a b
" Natalya in a few words or phrases: resilient, focused, insatiable desire to learn, and receive feedback better than anyone. More specifically, Natalya helped navigate and transform our company into a medical device coating company through her intense focus and determination to obtain ISO13485 certification. In the process, we became a better company. She leads through example and like most leaders is resilient and persistent in driving results. One of Natalya's endearing qualities is her ability to learn. There is nothing that she can't master, and her insatiable curiosity makes her a great team member. Her desire to learn is infectious. Learning requires one to be able to receive feedback and take that feedback and self correct. Never defensive, I've never seen anyone in my career receive feedback as well as Natalya. She has accomplished a tremendous amount in such a short time, and I expect great things from Natalya in the years ahead."
Robert DeAngelis
Principal at Precision Coating Company,Inc.
"Natalya brings a refreshing combination of positive and professional engagement with determination and strong work ethic. Whether preparing quality management system for an ISO:13485 certification or organizing a response to a medical manufacturing non-conformity, she works to deliver results that meet high standard and underlying continuous improvement."
Tim Cabot
President & CEO at Katahdin Industries
President Precision Coating
Chairman of Southworth International
"When Natalya joined Avedro we were in the very early stages of developing an Orphan medical device/drug combination product. At that time, no one at the company had experience with combination products so we all had to learn together, each contributing where we could. Natalya was not intimidated by the daunting task and jumped right in taking a leadership role. As we were a small company, all of us needed to wear many hats yet Natalya was able to step up, learn what was needed and pass that specific knowledge on to the rest of the team. She interacted with all departments, including technical and marketing, supplying them with the support they need to fulfill their individual mandates. I have followed her career since she left Avedro and she has continued to study, learn and extend her knowledge and capabilities. Along with her broad background in Quality and Regulatory management, she brings a "no fear" approach to solving difficult problems Her ability to bring the necessary resources together, either as a single contributor or team organizer, positions her and DQRS to be an ideal partner to help companies navigate the difficult FDA pathway required to get products through the approval gauntlet."
David Muller, PhD
Allotex, Inc. Founder & CEO
Testimonials
Testimonials
Testimonials
" I highly recommend “Devices QR Services Inc. (Natalya Koshnitsky) for medical device Quality System and Regulatory consultation. Natalya is an experienced and knowledgeable Quality and Regulatory professional who has recently supported Boston Microfluidics’ Quality System and Regulatory initiatives. She is an effective communicator and
" I highly recommend “Devices QR Services Inc. (Natalya Koshnitsky) for medical device Quality System and Regulatory consultation. Natalya is an experienced and knowledgeable Quality and Regulatory professional who has recently supported Boston Microfluidics’ Quality System and Regulatory initiatives. She is an effective communicator and completed assigned projects on time as planned. "
Scott Robinson
Quality Manger at Weavr Health
" Natalya and her team have worked with us at Edge for over a year, and they've done an amazing job helping us not only build our quality management system, but to instill a culture of quality throughout the company. Her work with us includes all the nuts and bolts we need to ensure quality processes are in place, and also passing along wisdom and experience to my team. She's made our entire company better, and I feel very safe in her hands."
Andrew Kamholz
CEO at Edge Precision Manufacturing