DMR SYSTEMS LIMITED specialises in the delivery of intelligent management system solutions to life-science companies. 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. 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 WHAT WE'VE ACHIEVED - 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