EN ISO 14971:2019/A11:2021 and EU MDR/IVDR Safety & Performance Requirements
- Services
- CE Certification Consultancy
- CE Consultancy for Medical Device
- CE Marking for Medical Device Manufacturers
- Technical Files for Medical Devices
- Risk Management for Medical Device
- General Safety and Performance Requirement (GSPR)
- Instruction for Use (IFU)
- List Of Applicable Standards
- SSCP
- Medical Device Testing
- Medical Device Labelling
- Usability
- Design History File
- Stability Study
- CE Consultancy for In Vitro Diagnostic Device (IVD)
- Preparation of Clinical Evaluation for Medical Device
- Preparation of Post Market Surveillance Documents
- Notified Body Selection Service
- MDD Vs MDR – Gap Analysis
- European Authorized Representative (EAR)
- Unique Device Identification (UDI)
- European Database On Medical Devices (EUDAMED)
- European Free Sale Certificate (FSC)
- Medical Device (QMS)
- CE Consultancy for Medical Device
- CDSCO Approvals for Medical Devices
- UKCA Certification Consultancy
- US FDA 510(k) Approval for Medical Devices/IVDs
- Other Regulatory Services
- CE Certification Consultancy
- Pricing
- Blogs
- Careers
- RegXpert
- Contact Us
