Services
Eight pillars. One technical file. Every statement traceable.
Regulatory work is one file viewed from eight angles. These pillars are not a menu of unrelated services; each one feeds and is fed by the others, and every page says which. Start with the flagship if your question is biological safety; start anywhere else and you will be shown how it connects.
- 01 Global regulatory strategy and market access Which market first, by which route, with what evidence, and in what order. These are the decisions that set the cost of everything that follows, and they are too often made by default. Authentcare makes them in writing, with the rule and the guidance each one rests on. First deliverableClassification and pathway memo
- 02 Quality management systems and audits An audit has a date. A certificate is due for renewal. The FDA now inspects against a regulation that incorporates ISO 13485 and the procedures still say "DMR". Whichever brought you here, the first deliverable is the same — a gap assessment that reads like the audit report you are trying to avoid, with a closure plan you can run. First deliverableQMS gap assessment
- 03 Electrical safety, EMC and product compliance The laboratory asked which standards to test to and which edition, and the honest answer was a guess. The applicability matrix replaces the guess — collateral by collateral, particular by particular, with essential performance defined before anyone switches on a test chamber — and the report review catches what the test did not cover. First deliverableStandards applicability matrix and test plan
- 04 Risk management and product safety Every other file points at this one. The electrical-safety test plan, the biological endpoint rationale, the software hazard analysis and the post-market trend thresholds all draw on the risk file, and a reviewer who finds it thin stops trusting the rest. Authentcare builds the file so that each link in the chain can be followed, and challenges it before a reviewer does. First deliverableRisk-file review
- 05 Technical documentation and design controls This is where the other seven pillars meet, because the technical file is the only place a reviewer sees them together. The work is to make it complete, traceable and navigable, so that a reviewer finds each piece of evidence where the general safety and performance requirement says it should be, and finds nothing contradicting it elsewhere. First deliverableTechnical documentation gap report
- 07 Software, SaMD and cybersecurity A software device faces three rulebooks at once — the device regulation that classifies it, the cybersecurity expectations that have become premarket requirements, and, in the EU, the AI Act if it learns. Treating them as three projects produces three contradictory documents. Authentcare produces one plan with one document inventory and one sequence. First deliverableIntegrated SaMD regulatory plan
- 08 Post-market surveillance and lifecycle compliance The certificate is issued and the device is on the market, and the obligations have just begun. A PMS system that only collects complaints misses the signals, misses the deadlines and leaves the PSUR to be written from memory. Authentcare builds the system so that each report is produced from data the system already holds, on the cadence each market sets. First deliverablePMS system review
How the pillars connect
Risk management sits at the centre: it feeds the electrical-safety test plan, the software hazard analysis, the biological evaluation's endpoint rationale and the post-market trend thresholds, and it is fed back by every one of them. Technical documentation is where all eight meet, because the technical file is the only place a reviewer sees them together. Regulatory strategy decides the order in which the rest is done, and for which markets. Quality management decides whether any of it can be repeated.
That is why each pillar page ends with a "How this connects" block rather than an unrelated list of other services. Choosing where to start is itself a regulatory decision; the scoping call exists to make it.
What "Direct", "Coordinated" and "Scoped per engagement" mean
Every service component carries one of three capability designations, set out in full on the scope and limitations page. Direct means the consultant delivers the full scope. Coordinated means Authentcare plans, briefs and reviews, and a named partner executes: a laboratory tests, a sterilisation contractor validates, a specialist firm penetration-tests. Scoped per engagement means the service is offered with a separately named qualified collaborator — a clinical specialist for clinical evaluation, an IVD scientist for performance evaluation — and the scope names them. No page on this site describes a capability that does not carry one of these designations.
Coordinated with specialist partners
Planning, documentation and coordination only. Execution sits with validation laboratories, sterilisation contractors, clinical collaborators or the manufacturer, named per project.
| Sub-offer | Parent pillar | What Authentcare does | Current editions cited |
|---|---|---|---|
| Sterilisation validation planning | 02 QMS | Define the validation strategy, review protocols and reports, integrate into the medical device file | ISO 11135:2014+A1:2018; ISO 11137-1:2025, -2:2013, -3:2017, ISO/TS 11137-4:2020; ISO 17665:2024 |
| Packaging and shelf-life | 05 Technical documentation | Define the packaging validation plan, review ISO 11607 evidence, link to labelling and transport simulation | ISO 11607-1:2019+A1:2023; ISO 11607-2:2019+A1:2023 |
| Microbiology and bioburden | 06 Biological evaluation | Scope bioburden, sterility and endotoxin requirements; coordinate laboratory work | ISO 11737-1:2018+A1:2021; ISO 11737-2:2019; ISO 11737-3:2023 |
| Cleanroom qualification | 02 QMS | Define the classification and monitoring plan | ISO 14644-1:2015; ISO 14644-2:2015 |
| Reprocessing of reusable devices | 05 Technical documentation | Define reprocessing instructions and the validation evidence required | ISO 17664-1:2021; ISO 17664-2:2021 |
| Usability engineering file | 07 Software, SaMD | Plan and document the usability engineering process; coordinate formative and summative studies | IEC 62366-1:2015+A1:2020; IEC 60601-1-6 where applicable; current FDA human factors guidance |
| Clinical investigation and IVD performance study planning | 06 Clinical and IVD evaluation | Protocol-level regulatory input; ethics and authority submission coordination, with a named clinical or IVD collaborator | ISO 14155:2026; ISO 20916:2019; MDR Chapter VI; IVDR Chapter VI |
| Product environmental compliance | 03 Product compliance | Applicability assessment and declaration support | RoHS Directive 2011/65/EU as amended; REACH Regulation (EC) 1907/2006; WEEE Directive 2012/19/EU |
Not sure which pillar your problem sits in?
Most engagements start in one pillar and touch three. A scoping call places it.