What Authentcare is not
- Not an accredited testing laboratory. Electrical safety, EMC, biocompatibility, sterilisation, packaging and software penetration testing are performed by accredited laboratories or specialist firms. Authentcare plans the testing, briefs the laboratory and reviews the report.
- Not a notified body, certification body or auditing organisation. Authentcare prepares and audits internally; CE certificates, ISO 13485 certificates and MDSAP certificates are issued by bodies accredited to issue them.
- Not a law firm. Regulatory consulting is not legal advice. Contract, liability, intellectual-property and litigation questions go to counsel.
- Not a statutory representative in any market. Authentcare does not act as EU Authorised Representative, Person Responsible for Regulatory Compliance, UK Responsible Person, Swiss Authorised Representative, US Agent, Indian Authorised Agent, Australian Sponsor or Canadian importer of record. It coordinates the appointment of these roles and helps you meet their requirements.
- Not a clinical research organisation. Clinical investigations and IVD performance studies run under sponsor and ethics-committee control; Authentcare contributes regulatory input to protocols and submissions, with a named clinical or IVD collaborator.
Capability register
Each service component carries one of three designations. The designation is stated on the service page and governs what that page may say.
| Service component | Designation | What that means |
|---|---|---|
| 01 Regulatory strategy and market access | Direct | Full scope delivered by the consultant |
| 02 QMS design, gap assessment, internal audit, MDSAP readiness, CAPA, supplier control | Direct | Full scope |
| 02 Process validation (sterilisation, cleanroom) | Coordinated | Planning and review only; execution by validation partners |
| 03 Electrical safety and EMC: applicability matrix, essential performance, test planning, report review | Direct | Consulting scope; no test execution |
| 03 Laboratory testing | Coordinated | Accredited laboratories named per project |
| 04 Risk management | Direct | Full scope |
| 05 Technical documentation and design controls | Direct | Full scope |
| 05 Packaging and reprocessing documentation | Coordinated | Planning and review only |
| 06a Biological evaluation, TRA, E&L, breathing-gas pathway | Direct, flagship | Full scope |
| 06a Laboratory testing and microbiology | Coordinated | Laboratories named per project |
| 06b Clinical evaluation and clinical investigation planning | Scoped per engagement | Offered with a named clinical collaborator; dedicated page in preparation |
| 06c IVD performance evaluation and performance studies | Scoped per engagement | Offered with a named IVD collaborator |
| 07 Software, SaMD, cybersecurity and AI regulatory strategy and documentation | Direct | Full scope |
| 07 Software verification, penetration testing, usability studies | Coordinated | Executed by the manufacturer or specialist firms |
| 08 Post-market surveillance and vigilance | Direct | Full scope |
| Statutory representation (all markets) | Coordinated | Appointment coordination only |
What every engagement excludes
Unless a written scope says otherwise: laboratory and testing fees; notified-body, certification-body and regulator fees; representative and agent fees; travel; the execution of validation, testing or clinical work; filing on your behalf in portals that require the manufacturer's own credentials, unless you grant them under a written authorisation; and legal advice.
On outcomes
Authentcare does not guarantee clearance, approval, certification, licence grant, audit results or the absence of findings. Those decisions belong to regulators, notified bodies and auditors, and they depend on the device, the evidence and the manufacturer's own controls as much as on the file. What Authentcare commits to is stated in each offer: a defined scope, a defined output, a timeline from receipt of inputs, and a deliverable in which every statement can be traced to its source.