A new consultancy concept, we not only bring expertise and experience to a particular problem, we are fully scalable to deliver whatever solutions your business may need now or in the future.
Our Mission
In a rapidly changing world and evolving regulatory landscape DMR SYSTEMS LIMITED aims to provide diverse management system solutions to the life sciences industry. With a core strength in quality management we also offer business continuity and information security services to allow our clients to build and maintain truly fit for purpose consolidated management systems.
Since our foundation in early 2017 we have been able to provide continued success to our customers by providing solutions rather than simply services.
What We've Achieved
CLASS III PMA QUALITY SYSTEM DESIGN, USA
MULTI-SITE GOBAL MEDICAL DEVICE AND PHARMA QMS DESIGN, GERMANY / WORLDWIDE
MEDICAL DEVICE SITE VALIDATION QUALITY OVERSIGHT, ISRAEL
QUALITY MANAGEMENT MEDICAL DEVICE DUE DILIGENCE, EUROPE
MULTI-SITE ISO 13485:2016 & MDSAP QMS TRANSITION, EUROPE & USA
ISO 13485:2016 & MDSAP SUPPLIER AUDITING, EUROPE & NORTH AFRICA
ISO 9001:2015 & cGMP SUPPLIER AUDITING, EUROPE
ISO 13485:2016 & MDSAP CORPORATE AUDITING, EUROPE & ASIA
FDA INSPECTION MOCK AUDIT & PREPARATION, EUROPE
Skills and Expertise
EU MDR 2017/745 Medical Device Regulation
MDD 93/42/EEC Medical Device Directive
ISO 13485:2016 Quality Management Systems Requirements - Medical Device
FDA 21 CFR 820, 803, 806 Medical Device
Medical Device Single Audit Program (MDSAP)
ISO 22301:2014 Business Continuity Management Systems (BCMS)
ISO 27001:2013 Information Security Management Systems (ISMS)
ISO 9001:2015 Quality Management Systems Requirements (QMS)
FDA 21 CFR 210, 211 Finished Pharmaceuticals
FDA 21 CFR 4 Combination Products