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Flexible and scalable
specialist support
With compliance projects
There are three ways we can help:
Deliverable-based projects
Departmental process outsourcing, for cost-effective and sustaining projects
What makes elemed compliance
projects different?
We deliver high-quality experts quickly, at a reasonable price
Slide to reveal what you can expert from elemed ✨
Frequently asked questions
How do you find your consultants?
We have an extensive network of experienced mid to senior level consultants in our elemed community.
What skill sets do you cover?
- Quality, regulatory and clinical
- Data science, digital health and AI
- Cybersecurity in MedTech
- CDx
- Sustainability
- Microbiology and toxicology
Where are your consultants based?
We have supported companies in:
- DACH
- Scandinavia
- Northern Europe
- Southern Europe
- France
- BENELUX
- US
How long does it take to get someone started?
We will deliver a shortlist of fantastic consultants to you within 48 hours. Consultants usually start working within 10 days. This means that you could have exceptional project support within your team within two weeks from when you first contact us!
What is the minimum duration I can hire a consultant for?
Whilst there is no official contract duration, the standard market minimum is three months.
Can you guarantee confidentiality and that our consultant won't work with a competitor?
All of our consultants will typically sign a basic NDA. Most of our customers prefer using an enhanced one for particular projects. Get in touch and we can discuss this in more detail.
Can we hire the consultant full time if we're really impressed or the need arises?
This depends entirely on the consultant and their career plan, but it is possible! Speak to us first and we’ll facilitate the conversation with the consultant to gauge their interest.
Where can I learn more about elemed?
This depends entirely on the consultant and their career plan, but it is possible! Speak to us first and we’ll facilitate the conversation with the consultant to gauge their interest.
The project support we 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
Let's work together
We can help you to:
Hire exceptional specialists quickly
Achieve your business goals
Ensure complete compliance
Arrange a callback
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