Vetting | Medical Device Manufacturing

StatusA company enters the programme in three steps. It claims its page, which a person here reviews, it chooses the categories it works in, and it asks to be verified from its own account. The ask is what starts a cycle: the checks below are per wing, and the categories are what say which wing. On the Products wing the four checks are reads of records this site already holds and run without a person. On the Services and Materials wings most of the checks are things somebody does in the world, and a person here does them. This page is the definition of the word, and it is the whole of it.

The word

Vetting is the name of the programme. Verified is the dated stamp on a completed check. Nothing in this programme is an on-site examination by a qualified party, so we do not use a word that would say it is.

Verification is never for sale. It cannot be bought at any price, by a sponsor, by the publisher, or by anyone else. It is earned by passing the checks and kept by passing them again every year.

Services wing: six checks

These are the checks, all of them, in this order. There are six and there is no seventh.

FDA establishment registration checked against the registry.
ISO 13485 certificate confirmed with the issuing registrar.
Facility confirmed at the stated address.
Category capability confirmed by documentation review.
One completed buyer reference call.
Enforcement history clean in MDM’s FDA records, with a ten year lookback.

Both credentials are required, not either. A company with an FDA establishment registration and no current ISO 13485 certificate does not pass, and neither does the reverse.

Two of the six, the registration check and the enforcement lookback, are read from the FDA data this site holds. The other four are things a person does: a call to a registrar, a facility confirmation, a document review and a reference call. They are run by MDM’s vetting operator, on the members who have asked to be verified, oldest ask first. There is no automatic path on this wing, and all six have to pass. Two of six is not a badge.

Products wing

Finished device manufacturers and distributors are checked against the FDA data this site already holds. Every one of the four checks is read from that data, so the whole of this wing is automatic: a Products verification is granted when all four pass, and a person reviews only the ones that do not. There is no reference call and no document review on this wing, so a Products badge says less than a Services badge while the face carries the same word.

FDA establishment registration current.
Device listings live.
Clearances on record.
A domain verified claim of the company page, so the person editing the profile controls the company’s own domain.

Rechecked automatically every year, with a person reviewing the exceptions.

Materials and equipment wing

A real company.
A real facility.
A verifiable product line.
One customer reference.

Annual. All four are things a person confirms, and nothing this site ingests can answer them. They are run by MDM’s vetting operator, on the same queue and in the same order as the Services checks: a member asks from its own account, and all four have to pass.

Claiming is not verification

Claiming a company page shows that the person claiming it has a mailbox on a corporate domain and one of the company’s own FDA identifiers, and it makes the page editable. It is not verification and it carries no badge. On the Products wing the claim is one of the four checks, and because the other three are read from FDA data, a claimed Products page whose registration is current, whose listings are live and whose clearances are on record is verified on the next automatic check with no person involved. On the Services and Materials wings a claim is not a check at all. It is the door into the programme, because there has to be a quality contact to give notice to before a verification can be lapsed, suspended or revoked.

What verification does not cover

No financial checks. We do not run credit checks, we do not read financial statements, and we make no statement about a company’s solvency.
No insurance tracking. We do not collect, hold or monitor certificates of insurance.
No on-site work. Nobody from MDM visits a facility as part of this programme. The facility check confirms the company operates at the address it states, and that is its whole scope.
Annual, not quarterly. A verification is a statement about what was true when the check was run, and every item is rechecked once a year. Anything can change between checks.
The enforcement check reads only the FDA records this site ingests. Recalls and enforcement reports are in that set. Form 483 observations and consent decrees are not published in a form the pipeline ingests, are not checked, and are not part of this. Where they matter, they are reported in the publication, sourced and bylined.
No performance figures. MDM publishes no delivery, quality or responsiveness figure about any member, because it holds none.

The two sentences that matter mostVerification is not an endorsement. It does not replace the buyer’s own supplier qualification. It tells you that a small number of specific, checkable facts were checked on a date, by us, against a named source. Qualifying a supplier for your product is your work and this does not do it.

The annual cycle

An active verification has a renewal date a year after it is granted, and every item is rechecked before renewal. A renewal notice to the member’s quality contact falls due at least fourteen days before that date. The annual cycle runs until the verification is renewed, lapses, or is suspended or revoked. A verification that is not renewed can lapse only once its renewal date has passed, and never sooner than fourteen days after the renewal notice is sent, so a notice that goes out late moves the lapse later. The renewal is the platform’s yearly conversation with every member, which is the reason verification is renewed every year and not less often.

Badge statuses

There are four and there are no others.

Active: Verified and inside the annual cycle.
Lapsed: The cycle passed without re-verification. The badge grays wherever it is mounted and the profile says re-verification is due.
Suspended: A hold pending review, entered only from a match against MDM’s own ingested FDA records and never from editorial judgement. That is a rule we hold ourselves to rather than one the system enforces, and the notice that precedes a suspension names the record relied on, so a member can see whether it was kept. When the suspension takes effect, the badge grays wherever it is mounted.
Revoked: Removed for cause, or ended when a member releases its own page. The badge is removed and the profile shows no badge.

We do not lapse, suspend or revoke a verification without first sending notice to the member’s quality contact. The notice shows the record relied on, and the change cannot take effect until fourteen days after the notice is sent, the same fourteen days the renewal notice gives. A notice that was not sent cannot be acted on. A response inside that window is recorded against the notice. The one exception is the member’s own decision: a member that releases its own page ends its verification with it, at once and without notice. Where a search returns nothing, that is recorded as not applicable, never as a failure.

How the badge works

The badge is served from this domain rather than copied onto a member’s site, so a status change takes effect everywhere at once and nobody has to chase a takedown. Every badge links back to the member’s public profile, where the checks, their dates and the current status are all visible. The verification you can inspect is the product; the image on their site is the pointer to it.

The badge face carries a status word and the month and year of the last verification, and nothing else: never a score, a rank or a grade. On a lapse or a suspension the word changes as well as the colour, so a reader who cannot see the grey is not told a lapsed badge is current. On revocation the image stops being served, so the badge disappears from the member’s site with no takedown to chase, and the verify address keeps resolving to the record, which says the verification was withdrawn. A verify address on this domain that does not resolve at all was never issued by us.

How requests are routed, and what the publisher’s own position in the network is, are on network rules. The directory itself is described on suppliers.