A quality system proportionate to where you actually are
“Everyone says I need a QMS. Do I need one now, and how much of one?”
The failure mode here runs in both directions and the expensive one is not the one founders fear. A twelve-person company that installs an enterprise quality system spends a year administering it; a company that installs nothing arrives at its first audit with no design history and no way to build one retrospectively.
WHAT THIS IS NOT
Orientation for translating research toward a regulated product — not a determination of device status, regulatory pathway, submission type or clinical adequacy, and not a substitute for qualified regulatory advice. SPEQ is independent: linked institutions, incubators and agencies are third parties, and nothing here implies affiliation, endorsement or partnership with any of them.
ARE YOU HERE?
- Someone — an investor, a partner, a contract manufacturer — has asked whether you have a quality system
- You have procedures in the sense that people know how things are done, and not in the sense that anyone could read them
- A consultant has quoted for a full QMS implementation and you cannot tell whether it is proportionate
WHAT TO DECIDE NOW
- Which processes genuinely need control NOW — usually design control, document and record control, and supplier oversight, because those three produce records you cannot recreate later
- What is deliberately deferred, written down as deferred rather than simply absent, so the decision is visible and revisitable
- Who owns quality, even if it is you part-time. An unowned quality system does not degrade gracefully; it stops.
START KEEPING THESE RECORDS NOW
- Design history from the beginning — the inputs, the decisions and why alternatives were rejected. This is the record most often missing and least possible to rebuild.
- Supplier and contract-organisation selection rationale, because oversight of an outsourced activity is a responsibility that never transfers with the work
- Training and competence for anyone performing work that will support a submission, including yourself
THE PROBLEM THIS ANSWERS
A quality system is treated as a single all-or-nothing artefact bought at a milestone, rather than as a set of controls that each become worth their cost at a different point.
What it costs: Either it arrives too late to have produced any record, or it arrives so heavy that it is not used — and an unused system produces the same evidence as no system.
NOT YET MEASURED — Assessment completions originating from the startup surface rather than from the maturity hub.
WHERE THIS GOES WRONG
- Buying an eQMS before knowing what processes it will hold. The tool then defines the process, and the process is somebody else’s.
- Starting the quality system at manufacturing. Design control produces the records earliest and is the part that cannot be added afterwards.
- Treating ISO 13485 certification as the goal rather than as evidence. Certification of a system nobody follows is a finding waiting to be made.
WHAT THIS DOES NOT ANSWER
- Which standard your system will eventually be certified or inspected against, which follows from the product and the market rather than from preference
- Whether a phased implementation satisfies a specific partner’s diligence, which is a question for that partner
OFFICIAL SOURCES · INDEPENDENT THIRD PARTIES
21 CFR Part 820 as it stands from 2 February 2026, incorporating ISO 13485:2016 by reference.
FDA — Design Control Guidance for Medical Device Manufacturers ↗What a design history file is expected to contain, which is the record founders most often start too late.
GO DEEPER ON SPEQ