One Audit. Five Regulators. If You Run It Once, Run It Right.
Medical Device Single Audit Program strategy — a single quality-system audit that five regulators accept, mandatory for Canada and a shortcut into four more markets when it’s prepared, not just passed.
Five Regulators Agreed to Read the Same Audit.
An MDSAP audit is conducted by a recognised Auditing Organisation against ISO 13485 plus each participant’s specific requirements. One report, accepted by all five — in place of most of their separate routine audits.
FDA
Accepts MDSAP in lieu of most routine device inspections.
Health Canada
Requires MDSAP — the certificate underwrites every Class II–IV licence.
TGA
Accepts MDSAP evidence toward conformity assessment.
ANVISA
Accepts MDSAP reports toward its GMP requirements.
MHLW / PMDA
Accepts MDSAP toward its QMS conformity review.
Most Companies Meet MDSAP Because Canada Makes Them — Then Discover the Upside.
Of the five participating regulators, Canada is the one that requires the certificate: no MDSAP, no Medical Device Licence. So MDSAP usually arrives on the agenda as a Canadian obligation — and companies that treat it that narrowly miss what it’s worth.
Prepared properly, the same audit that unlocks Canada displaces most of FDA’s routine inspections and satisfies Australia, Brazil, and Japan. One well-run quality system, audited once, carries five markets — which turns a compliance cost into a market-access asset.
The audit is against ISO 13485 plus each country's specifics — run once, read five times.
Six Disciplines That Carry an MDSAP Certification.
The certificate is passed in the audit room and earned in the months before it.
Readiness & Gap Assessment
Your quality system read against the MDSAP model and each regulator’s specifics — the gaps found and closed before the Auditing Organisation finds them.
Auditing Organisation Selection
The right recognised AO chosen and scheduled — scope, timing, and the country-specific requirements that apply to your markets agreed up front.
Process-Based Preparation
Preparation built around MDSAP’s process approach — management, design, production, and the linked processes the audit traces end to end.
Audit Management
The audit run as a managed event: the right people, the right records, and the difficult processes rehearsed — so findings are the exception, not the theme.
Surveillance & Recertification
The three-year rhythm owned — surveillance audits and recertification planned so the certificate never lapses between cycles.
Nonconformity Response
Audit findings graded and answered with real corrective action — the response that keeps a finding from escalating and the certificate on track.
Five regulators read the same graded report — a serious nonconformity is not a local problem.
MDSAP Grades Its Findings. A Bad One Can Reach FDA and Health Canada.
MDSAP nonconformities are scored, and the grade drives what happens next — and because five regulators receive the report, a serious finding is not a private matter with one auditor. It can trigger regulator action in the markets that rely on the certificate.
We prepare for the grading, not just the checklist — and tie MDSAP into the same quality system and inspection readiness discipline that carries an FDA visit, so one program answers to all of them.
Six Failure Modes We Are Brought In to Prevent.
Passing once is easy to underprepare for and expensive to fail.
Treating it as Canada-only
Preparing MDSAP as a narrow Canadian box-tick — and forgoing the FDA, TGA, ANVISA, and PMDA value the same audit could have delivered.
The AO chosen on price
An Auditing Organisation picked on cost and calendar rather than fit — and a scope that doesn’t cover the markets you actually sell in.
Checklist prep for a process audit
Preparing to clauses when MDSAP audits processes end to end — and coming apart where one process hands off to the next.
Underestimating the grade
Answering a graded nonconformity as if any finding is equal — until the score triggers attention from a regulator downstream.
A lapsed certificate
Surveillance or recertification missed in the three-year cycle — and a Canadian licence suddenly resting on an expired certificate.
Two systems, one company
Running a separate MDSAP file beside the real quality system — the parallel-paperwork failure that the first process trace exposes.
MDSAP Preparation From People Who Have Been in the Room.
Our quality leads have prepared companies for MDSAP, hosted the auditors, and answered findings across all five regulators.
“MDSAP is the best deal in device regulatory — one audit for five markets. The catch is that one audit also fails you in five markets. Prepare for the leverage.”
The discipline we bring to single-audit programs.
Facing an MDSAP Audit — or a Canadian Licence That Needs One?
A senior quality lead can assess your readiness, choose the Auditing Organisation, and prepare the processes before the audit date decides your outcome.
Senior-led. Embedded in your team. No junior hand-offs.