MDR: Software Validation New Regs
Zener Engineering Services Ltd • 22 November 2019
Are You Ready for the New Regulations?
The transition periods for the new MDR and IVDR regulations began on the 26 May 2017. The transition periods will last for three and five years. Therefore, the MDR and IVDR will fully apply in EU Member States from the 26th May 2020 and 2022 respectively.
ZES are experts in Medical Device software validation, in line with MDR, IVDR, ISO 13485, GAMP 5 guidance and IEC 62304.
ZES Medical Device Software Validation Services Include:
- Medical Device Validation Plans and Summary Reports
- Validation Gap Analysis
- Position Statements
- Risk Assessments
- Software Validation
- Inventory Management
- Validation Strategy Implementation Adopting a Risk-Based Approach
- Electronic Record and Electronic Signature Assessment and Remediation
- CSV Training Delivered by Industry Experts
- Full Life Cycle Documentation Generation and Protocol Execution
Download the Medical Device Services leaflet for more details.
Download the Medical Device Services leaflet for more details.
ZES can also provide, and have experience of, the following:
- Regulatory advice and support for registration and conformity of medical devices in EMEA regions and emerging markets
- ISO 13485, MDR 2017/745, IVDR 2017/746, compliance advice and implementation
- Liaise with regulatory authorities and prepare meeting packages with relevant agencies
- Plan and organize registration submissions and registrations
- Create from scratch technical files
- Full new product development lifecycle experience from conception to commercialisation
- Achieve CE Markings
- 510(k) Clearances : Advice, Documentation Generation and Validation
- Manufacturing Facility Design, Project Management, Installation and Validation
- Ensure device construction complies with ISO 60601
- Ensure software complies with IEC 62304
- Software Validation
- Project Management / Review
- Implementation of a suitable management strategy for Medical Device Cyber Security
- Information Security to ISO 27001
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