General information, not device-specific advice
Everything published on this website — service descriptions, market guides, articles, checklists — is general information about medical device and IVD regulation. It is not a regulatory assessment of any particular device, and it is not a substitute for one. Whether a requirement applies to a device depends on its intended purpose, its design, its classification and its target markets, which this website cannot know.
No consultant-client relationship
Reading this website, sending an enquiry or taking part in a scoping call does not create a consultant-client relationship. That relationship begins when a written engagement agreement is signed. The scoping call is for scoping and fit; it does not provide device-specific regulatory advice.
No guarantee of outcomes
Authentcare does not guarantee regulatory clearance, approval, certification, licence grant, audit results or the absence of findings. Those decisions are made by regulators, notified bodies and auditors on the basis of the device, the evidence and the manufacturer's own controls.
Regulations change
Regulations, standards and guidance change, and this website describes them as they stood on each page's stated review date. Every regulatory page carries a last-reviewed date, a next-review date and a content status. A page marked "Superseded" or "Under review" should not be relied on for current requirements. Where a development is proposed but not in force, the page says so.
Not legal advice
Regulatory consulting is not legal advice. Questions of contract, liability, intellectual property, product liability or litigation should be put to qualified counsel.
Capability boundaries
Authentcare is not an accredited laboratory, a notified body, a certification body, a law firm or a statutory representative in any market. The scope and limitations page sets out the capability designation of every service.
Liability
To the extent permitted by law, Authentcare Private Limited accepts no liability for loss arising from reliance on the general information on this website. Liability under an engagement is governed by the engagement agreement.
- 2026-11-08 — Version 1.0, first publication.