Fast. Agile. Staffing
elemed is a MedTech talent management agency that connects medical device and diagnostic companies who are looking for support with compliance projects to exceptional MedTech consultants. Our MedTech talent management experts – with over 50 years of combined experience – work with the brightest MedTech talent in the world and specialise in sourcing consulting professionals for medical device and diagnostic companies that need project support.
What services does elemed offer for MedTech consulting?
elemed has an extensive network of MedTech consultants within our community, many of whom have decades of medical device experience and diagnostics.
Some of companies we have provided MedTech consultants for include:
- Global MedTech corporations
- Medical device and IVD manufacturers
- High growth MedTech startups
- Notified Bodies
- Contact research organisations
Our team of MedTech 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 ourselves, which means we can provide MedTech consultant with just the right profiles of talent and experience for whatever project you might have.
We have MedTech consultants available to work in the following locations:
- Northern Europe
- Southern Europe
What type of MedTech consultants can we help you to find?
Our network of MedTech consultants includes experts across all functions and specialisms. Since being founded in 2015, our network and community of MedTech consultants in the medical device and diagnostics industry has grown and grown. We now work with some of the most exceptional MedTech consultants and contractors in the industry who are ready and available to support your project right now. We can source fantastic consultants for medical device and diagnostic companies who are looking for support with compliance projects and need someone to start quickly.
Areas of support that our MedTech 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
What product types and specialisms do your MedTech consultants cover?
- Class I, II, III medical devices
- Software as a medical device and digital health
- Active and non-active medical devices
- Regulatory, quality and clinical
- Data science, digital health and AI
- Cybersecurity in MedTech
- Microbiology and toxicology
Why should I use elemed to find a MedTech consultant?
Our network of MedTech consultants is second to none. The elemed talent management team has deep knowledge of the various MedTech skillsets and specialisms, meaning we really understand the projects we recruit for and what make our consultants ideal for them.
What’s more, when you work with elemed we aim to deliver a shortlist of great MedTech consultants within 48 hours with a view to someone starting work with you within 10 days. We’re also much more cost-effective than traditional MedTech consulting alternatives!
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