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elemed is a medical device and diagnostics talent management agency that focuses on connecting MedTech companies with exceptional medical device consultants. Our team of medical device consultant experts work with leading medical device and IVD companies from around the world, specialising in sourcing consulting professionals for the US and European markets.
Learn more about how we find medical device consultants for your projects →
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Learn more about hiring an MDR consultant in our 101 guide →
What services does elemed offer for medical device consulting?
elemed has an extensive network of medical device consultants within our community, many of whom have decades of medical device experience.
Some of companies we have provided medical device consultants for include:
- International MedTech corporations
- Medical device and IVD manufacturers
- Medical device startups
- Consultancies
- Contact research organisations
- Notified Bodies
Our team of medical device talent management experts spend every day working with medical device and IVD consultants and companies, which means that they have an extensive knowledge of the complexities and nuances of medical devices. We know MDR from IVDR and understand the specific details between regulatory affairs, quality assurance and clinical affairs. We are experts in the different medical device and IVD therapeutic areas, and what our medical device consultants’ experience means for the companies we represent and the roles we recruit for.
Our medical device consultants are based in:
- DACH
- Scandinavia
- Northern Europe
- Southern Europe
- France
- BENELUX
- US
What type of medical device consultants can we help you to find?
We specialise in medical device consultants across all functions and specialisms. Since launching in 2015, our network and community of medical device consultants in the MedTech industry has grown and grown. We now work with some of the most exceptional medical device consultants and contractors in the MedTech industry. This highly engaged and ever growing network enables us to source fantastic consultants for medical device and diagnostic companies who are looking for support with compliance projects.
Areas of support that our medical device consultants can offer:
- Global regulatory strategy support
- Gap assessments of technical documentation (e.g. CE, 510(k); De Novo; PMA, etc)
- Support Design Control, DHF creation, Risk Management, EUDAMED (UDI), etc
- EU CE mark NB/CA submissions (significant changes, variations and amendments)
- SME support (e.g. therapeutic area, regulator experience, etc)
- EU MDR/IVDR – Sustaining/Maintenance programs post CE approval
- NB/CA audit questions response support
- FDA 483 and warning letter responses
- Project File/Device History File remediation
- CE mark Technical Documentation remediation – EU MDR/IVDR
- Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PERs)
- PMS activity (PMS Plans, PMCF, PSUR)
- Summary of Safety and Clinical Performance (SSCP)
- Summary of Safety and Performance (SSP for IVDs)
- MDR and IVDR Clinical Support
- Sustaining and Maintenance CER/PERs/PMS
- ISO 13485, 21 CFR 820 and MDSAP compliance support
- Economic Operator support (Mfg, Importer, distributor, packaging, supplier, etc)
- CAPA/NCR services
- Complaint handling and recalls
- Process QMS improvement
- Supplier Auditing/Assessments
- Internal Auditing
- Pre-FDA Audit Assessments
- Pre-MDSAP Audit Assessment
- MDR/IVDR Audit Assessment
- Audit readiness (SME, Corporate, etc)
- Validation Master Plan/Report review and remediation
- IQ, OQ, PQ validation
- Support FAT and SAT Process validation (Packaging, Sterilisation, CSV, etc)
- Performance Improvement (Kaizen, Mfg process improvement, Value Stream Mapping, etc)
- ISO 14971 Risk management framework and risk assessment
- dFMEA, pFMEA, uFMEA
- Risk controls, mitigation, and avoidance
- Design verification and activities
- Full Project life cycle management
- Project planning and KPI
- Project tracking to scope, milestone, budget, quality standards, etc Working/Steering/Executive Group participation
- Continuous improvement on standard methodology, tools, management, talent development, etc
Medical device and IVD product types and specialisms that our consultants specialise in:
- Class I, II, III medical devices
- Software as a medical device and digital health
- Active and non-active medical devices
- Diagnostics
- Regulatory, quality and clinical
- Data science, digital health and AI
- Cybersecurity in MedTech
- CDx
- Sustainability
- Microbiology and toxicology
Why should I use elemed to find a medical device consultant?
Our network of medical device consultants is second to none. We pride ourselves in our deep knowledge of the medical device skillsets and specialisms, which enables us to really understand the projects we recruit for and what make our consultants ideal for them.
We aim to share a shortlist of great medical devices consultants with you within 48 hours, and our consultants start on average within 10 days from our first conversation. We’re also much more cost-effective than traditional medical device consulting alternatives, offering flexibility to suit your budgets, needs and project timelines.
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