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