Go back to > One Integrated Solution
Partner with the
highest quality
MedTech consultants
Accelerating safe,
life-improving devices
to market
No one is better placed to find exceptional compliance consultants than elemed Consulting
We listen, assess, and provide tailored solutions based on your project needs.
Our origins in search and talent mean we are experts in finding and vetting the highest quality consultants.
Our strong network and relationships enable us to match you with the ideal person, skillset and experience for your project requirements, whether they are strategic or tactical.
The outcome? Higher quality work, increasing your speed to market and impacting patient lives sooner.
100% consultant assessment and placement effectiveness
Have someone start within 10 days
24-48 hours average shortlist turnaround for Interim support
3:1 CVs to placement ratio where CVs are sent
elemed Consulting can support with:
- 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
- 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
- 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
There are three ways we can help:
We provide expert project management, precisely defining scope and deliverables, and using a structured, results-driven approach for success.
Urgent support to strengthen the team during peak workloads, maternity leave, or specialised tasks.
Any Quality or Regulatory function that can be outsourced, such as CERs, PMCF, audits, and complaints management.
Case studies
The project:
Support Post Market Clinical Follow-up (PMCF) for product portfolio, covering PMCF plan, protocol, deployment and report writing.
The deliverables:
Clinical writer and regulatory support with biostatistician expertise.
The result:
Successful authoring of plan protocol and regulatory and clinical support for the local team to enhance understanding and future proofing for maintenance support.
Ongoing project
Infection prevention leading company in Europe (<$100M, Rev)
The project:
Review the design control process for two business units and establish working efficiencies
The deliverables:
Design Quality and Project Manager to support steering committee and working groups in relation to reviewing and streamlining the design control process.
The result:
Successful planning and future structure proposed. Next phase shall be implementation.
Ongoing project
Large delivery system company in Europe (>$0.5B Rev)
Frequently asked questions
What types of consulting services do you offer?
We offer project consulting, Interim support, and managed outsourcing.
What makes elemed different?
Our origins in search and talent mean that we know the best people for the job, whether we already have established relationships or need to use our experience to vet new people. Being able to partner you with the highest quality consultants means faster speed to market, higher chances of product success, and the chance to ultimately improve patient lives sooner.
How do you find your consultants?
We have an extensive global network of consultants from Senior Director to Associate level to support strategic and tactical delivery projects.
What skill sets do you cover?
Core services:
Speciality services:
- Quality
- Regulatory
- Clinical
- Project/Programme management
Speciality services:
- Data science, Digital Health and AI/ML
- Cybersecurity
- CDx
- Sustainability
- Microbiology and toxicology
Where are your consultants based?
Europe and the US, but we have supported global projects with occasional local travel and can also support projects remotely.
How long does it take to get someone started?
If you have an urgent need for Interim support, 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?
This is dependent on the nature of consulting need and can be tailored to the key deliverable to maximise value add to our clients
Can you guarantee confidentiality and that our consultant won't work with a competitor?
Elemed consultants have NDA agreements in place to cover confidentiality requirements.
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?
In addition to consulting services, we support recruitment services and skills development. Find out more here.
Let's work together
We can help you to:
Partner with our consultants to drive business success
Maintain regulatory compliance
Deliver highly skilled consultants
quickly
Arrange a callback
WE'RE Here To Assist You
Let’s get to know each other
Have a free, personalised, career consultation with one of our experts. Learn about under-the-radar opportunities, salary insights and develop your career plan.