IMed Consultancy
IMed Consultancy specializes in medical device and in-vitro diagnostic (IVD) regulatory and quality compliance services. They assist companies with CE marking, quality management systems, auditing, global registrations, and navigating complex regulatory landscapes including MDR, IVDR, and other international standards. Their mission is to support the medical device industry in achieving compliance, safety, and market access through expert guidance, tailored strategies, and comprehensive documentation support.
Industries
Nr. of Employees
small (1-50)
IMed Consultancy
Bloxham, England, United Kingdom
Products
European Authorised Representative
Appointed European Authorised Representative (EUAR) services acting as the legal link between non-EU medical device and IVD manufacturers and European Competent Authorities to ensure MDR and IVDR compliance.
European Authorised Representative (EUAR)
Official independent representative services within the European Union under MDR and IVDR.
UK Responsible Person
Representation services acting as your UK Responsible Person and EU Authorised Representative to keep medical devices and IVDs compliant and on the market.
UK Responsible Person (UKRP)
Legal representation services for the Great Britain market, handling device registrations and technical documentation.
Regulatory Affairs Consulting
Expert regulatory affairs consulting services supporting medical device, IVD, and digital health companies through device classification, technical documentation, global submissions, and post-market compliance.
Combination Product Consultancy
Expert regulatory and quality assurance consulting services for combination medical devices, integrating drugs, devices, or biologics to achieve compliance across EU MDR, IVDR, and FDA frameworks.
European Authorised Representative
Appointed European Authorised Representative (EUAR) services acting as the legal link between non-EU medical device and IVD manufacturers and European Competent Authorities to ensure MDR and IVDR compliance.
European Authorised Representative (EUAR)
Official independent representative services within the European Union under MDR and IVDR.
UK Responsible Person
Representation services acting as your UK Responsible Person and EU Authorised Representative to keep medical devices and IVDs compliant and on the market.
UK Responsible Person (UKRP)
Legal representation services for the Great Britain market, handling device registrations and technical documentation.
Regulatory Affairs Consulting
Expert regulatory affairs consulting services supporting medical device, IVD, and digital health companies through device classification, technical documentation, global submissions, and post-market compliance.
Combination Product Consultancy
Expert regulatory and quality assurance consulting services for combination medical devices, integrating drugs, devices, or biologics to achieve compliance across EU MDR, IVDR, and FDA frameworks.
Services
Gap analysis and compilation of technical documentation to support device and QMS transition to the EU MDR and to achieve CE marking.
Gap analysis, technical documentation and performance evaluation planning to support IVD transition to IVDR and conformity assessment.
Identification of regulatory requirements for global markets and preparation of submissions for territories such as the US, Canada, Australia, Japan and Middle East.
Act as a UK-based responsible person for non‑UK manufacturers to interact with the UK regulator, register devices and fulfil statutory UK RP obligations.
Implementation and maintenance of QMS aligned to ISO 13485, 21 CFR Part 820 and MDSAP; internal auditing, management review support and CAPA completion.
Preparation and review of clinical evaluation reports, performance evaluation documentation, PSURs and other regulatory writing deliverables.
Gap analysis and compilation of technical documentation to support device and QMS transition to the EU MDR and to achieve CE marking.
Gap analysis, technical documentation and performance evaluation planning to support IVD transition to IVDR and conformity assessment.
Identification of regulatory requirements for global markets and preparation of submissions for territories such as the US, Canada, Australia, Japan and Middle East.
Act as a UK-based responsible person for non‑UK manufacturers to interact with the UK regulator, register devices and fulfil statutory UK RP obligations.
Implementation and maintenance of QMS aligned to ISO 13485, 21 CFR Part 820 and MDSAP; internal auditing, management review support and CAPA completion.
Preparation and review of clinical evaluation reports, performance evaluation documentation, PSURs and other regulatory writing deliverables.
Expertise Areas
- In‑vitro diagnostic regulatory compliance and IVDR transition
- Medical device regulatory strategy and MDR CE marking
- Quality management systems (ISO 13485) implementation and auditing
- Clinical evaluation and clinical/performance evidence strategy
Key Technologies
- Real-time PCR
- Lateral-flow immunoassays
- ELISA-based immunoassays
- Next-generation sequencing (NGS) data analysis
News & Updates
Client testimonials highlighting successful regulatory and compliance support, including MHRA authorizations and transition management.
Details of IMed's efforts to help medical device companies navigate regulatory challenges during the pandemic, including support for COVID-19 related devices.
An overview of the upcoming changes in EU IVDR regulation, including reclassification, safety and performance requirements, clinical evidence, and post-market surveillance.
Guidance on creating a comprehensive IVDR transition plan to ensure timely compliance and market access.
Explanation of how gap assessments can identify deficiencies and guide remediation efforts for IVDR compliance.
Guidance on preparing and presenting periodic safety update reports (PSUR) for medical devices.
Client testimonials highlighting successful regulatory and compliance support, including MHRA authorizations and transition management.
Details of IMed's efforts to help medical device companies navigate regulatory challenges during the pandemic, including support for COVID-19 related devices.
An overview of the upcoming changes in EU IVDR regulation, including reclassification, safety and performance requirements, clinical evidence, and post-market surveillance.
Guidance on creating a comprehensive IVDR transition plan to ensure timely compliance and market access.
Explanation of how gap assessments can identify deficiencies and guide remediation efforts for IVDR compliance.
Guidance on preparing and presenting periodic safety update reports (PSUR) for medical devices.