Venitara QMS Foundation
Company Ready
ISO 13485-aligned quality system foundation
A quality management system sized to your device and your team, with the registers filled in rather than the templates handed over.
Where this sits
01Pathway
Ready
02Market
Ready
03Company
ReadyYou are here
04Evidence
Ready
05Submission
Ready
06Revenue
Ready
Your file, growing. Each stage begins with the work already in it.
Available at any stage
When to use Company Ready
An audit has come into view, or development has become formal enough that responsibilities are spreading across people who have never held one.
A quality system bought as templates is a folder. A quality system your team can operate is a set of registers with entries in them, owned by named people, and it is the difference an auditor asks about first.
What you receive
The Operating QMS Foundation
The governing procedures, the responsibilities against named roles, and the core registers, set up so the system runs from the day it is handed over.
What it contains
Governance and the quality policy
Responsibilities assigned to named roles, including the PRRC under MDR Article 15
The core registers, populated rather than blank
The delta between ISO 13485 and MDR Article 10, stated explicitly
What the work covers
| Document | Read against |
|---|---|
| Quality manual and quality policy | ISO 13485, Clause 4 |
| Management responsibility | ISO 13485, Clause 5 |
| Design and development procedure | ISO 13485, Clause 7.3 |
| Document and record control | ISO 13485, Clause 4.2 |
| CAPA and nonconformity | ISO 13485, Clauses 8.3 and 8.5 |
| Manufacturer obligations delta | MDR 2017/745, Article 10 |
| PRRC appointment | MDR 2017/745, Article 15 |
Who does the work, and against what
The system is scoped to the device and the size of the team. ISO 13485 certification on its own does not discharge the manufacturer obligations in MDR Article 10, and the gap between the two is closed in writing rather than assumed away.
Venitara has worked in cooperation with ten to twelve Notified Bodies and delivered more than forty regulatory projects.
What you can do with the result
You can operate the system from the day it arrives, because the registers have entries and the roles have names.
Each person knows what they own, so quality stops being one person's argument with everyone else.
And when an auditor walks in, the answer to what happens when something goes wrong is a record rather than a description.
The three levels for this product
Explore | Attest | Certify | |
|---|---|---|---|
| What you get | Draft procedures built from your own answers | Each procedure read by a named senior expert and attested | The quality system and the complete technical file independently assessed |
| Human review | No expert review | Reviewed by a named senior regulatory expert | Assessed by senior regulatory experts who did not write the documents |
| What it may claim | An indicative working view | That this procedure was ready for submission on the date it was read | That the system was ready for submission on the date it was assessed |
| The mark | A notice that no regulatory expert has read it | The Attestation seal, on the document | The Certification seal, on the certificate |
The Venitara Attestation records that a named senior regulatory expert has reviewed this document against the Venitara rubric, confirming concordance with the applicable regulatory requirements and assessing it as ready for submission at a defined point in time. It is not a conformity assessment under Regulation (EU) 2017/745, regulatory approval, a Notified Body certificate, or a guarantee of approval.
Where Certification fits
Attest applies to this product, document by document. Certification is wider. It assesses your quality management system and the regulatory operation alongside the complete technical file, so it covers the whole path rather than one product on it.
Certification issues as a Certificate, and it includes an Attestation on every document inside the scope assessed.
Venitara Certification records an independent assessment of this organisation's regulatory system and technical documentation, performed by senior regulatory experts, confirming concordance with the applicable regulatory requirements and stating that the system is ready for submission at a defined point in time. It is not a conformity assessment under Regulation (EU) 2017/745, regulatory approval, a Notified Body certificate, or a guarantee of approval.
Scope and limits
Three things this product does not do
Certify your quality system to ISO 13485.
Certification against ISO 13485 is issued by an accredited certification body after an audit. Venitara builds the system and prepares you for that audit.
Sit your audit.
You hold the audit. What Venitara can do is make sure the person answering knows what the records say.
Take on the PRRC role by appointment.
The Person Responsible for Regulatory Compliance under MDR Article 15 is appointed by you. A fractional PRRC arrangement is available and is quoted separately.
Where this leads
Evidence Ready.
The evidence work happens inside the quality system, under the design and development procedure this product sets up.
Submission Ready.
The technical file is reviewed against the system it was produced in, so a Notified Body can see both together.
Common questions
We already have ISO 13485. Do we need this?+
Possibly not for the certificate, and possibly yes for MDR. Article 10 places obligations on the manufacturer that an ISO 13485 certificate does not by itself discharge, and the delta is what this product closes.
How big is the system for a team of five?+
Sized to the team. A system built for a company of two hundred will not be operated by five people, and an auditor can tell the difference between a system in use and one that was bought.
Who fills in the registers?+
Venitara populates them from your own answers and your existing records. You own them from handover, and keeping them current is yours.
Does this cover software?+
IEC 62304 lifecycle procedures are included where the device contains software. Cybersecurity documentation sits with the evidence work.
Need an expert read before the technical file leaves your company?
If you are still working out where to begin, the free MedTech Compass takes about ten minutes.
Free · AI generated · 10 mins