SMEDTEC OS
Regulatory & Quality Specialists | Medical Devices, Pharma, Cosmetics
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Summary
We are a UK regulatory and quality consultancy. Our clients are mostly early-stage manufacturers and brand owners, plus established SMEs who need one piece of work done properly. First device to market, a technical file that will not survive a notified body, a skincare range with claims nobody has substantiated, a QMS that exists as a folder of Word documents.
We are looking for a number of specialists across multiple disciplines to support with active and upcoming projects in the pipeline.
Medical devices and IVDs
- EU MDR and IVDR technical documentation, GSPR checklists, conformity routes
- Clinical evaluation: CERs, literature review, PMCF planning
- FDA submissions: 510(k), De Novo, PMA
- UKCA, MHRA registration, UK Responsible Person work
- ISO 13485 QMS build, remediation and internal audit
- ISO 14971 risk management
- IEC 62304 and IEC 62366-1 for software and usability
- Post-market surveillance, PSUR, vigilance reporting
- UDI and EUDAMED registration
- Labelling to ISO 15223-1 and ISO 20417
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Cosmetics and personal care
- Cosmetic Product Safety Reports, from qualified Safety Assessors
- PIF compilation, CPNP and SCPN notification
- Claims substantiation against the common criteria in Regulation (EU) No 655/2013
- ISO 22716 GMP
- MoCRA facility registration, product listing and safety substantiation
- Borderline work: cosmetic against device against medicinal, including MDR Annex XVI aesthetic products
Pharmaceutical
- GMP and GDP compliance and auditing
- CMC and regulatory submissions
- Pharmacovigilance
- Qualified Person work
If your discipline is adjacent and not listed, tell us anyway.
What the work looks like
Some of it is small and sharply defined. A gap analysis, a CER refresh, one safety assessment, a labelling review. Days, not months. Some of it runs alongside a client team for months: a full technical file, a QMS build, a submission carried through to clearance. We want people who can do both, and who are straight about which they prefer.
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Who this suits
Early-stage clients are messy. Documentation is missing, the intended purpose moves twice before you finish, and someone has usually already published a claim they should not have. We need people who work with that and say plainly what is missing, rather than going quiet and delivering something thin.
Writing matters here. Most of what we hand over is a document somebody else will be audited against.
We would far rather hear "that is a Safety Assessor question and I am not one" than receive a confident guess. Knowing the edge of your lane is a qualification in itself.
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