Medical Device Audit Services
Independent Medical Device Audits for ISO 13485, MDSAP, EU MDR and FDA
Risk-based internal audits, supplier audits, mock FDA inspections and QMS gap assessments, conducted on-site or remotely by qualified auditors with Notified Body experience.
An audit is only worth the time it takes if it finds what the Notified Body, the FDA investigator or the MDSAP auditing organisation would find, before they do. MD Regulatory provides independent audits for medical device manufacturers, suppliers and distributors, carried out with the same method and the same depth used in certification audits.
Every audit is risk-based: the sampling goes where the product risk, the regulatory exposure and the history of the quality system say it should, not evenly across every clause. The result is a report that tells you what to fix and why, with each finding traceable to the requirement behind it.
Medical device audit services
Five services, each available on-site or remotely, and each scoped to the standards and regulations that apply to your products and markets.
Internal audits
Planned audits of your quality management system against ISO 13485, 21 CFR 820, MDSAP or EU MDR, performed by an auditor independent of the activities audited, as clause 8.2.4 requires. A full-system audit or a single-process audit to complete your audit programme.
Supplier audits
Audits of critical suppliers and outsourced processes: contract manufacturers, sterilisers, component and material suppliers, software developers. The report gives you the objective evidence your supplier controls need.
Mock FDA inspections
An inspection simulated on the QSIT-style approach used by FDA investigators, now under the Quality Management System Regulation: management, design controls, CAPA, production and process controls, complaints and medical device reporting.
Supplier qualification
Assessment of a new supplier before it is approved: capability, quality system, regulatory status and risk to your product. A documented basis for the decision to add the supplier to your approved list.
QMS gap assessments
A structured comparison of your current system against a target framework — the transition to the FDA QMSR, an MDSAP certification, EU MDR or IVDR — with a prioritised list of the gaps to close before the certification audit.
Why outsource your medical device audits
Certification-audit experience
Audits are conducted by auditors who have audited manufacturers from the Notified Body side and know which evidence an auditor asks for and which answers do not hold.
Objectivity and independence
An external auditor has no stake in the processes audited and no internal relationships to protect, so findings are raised as they are found.
Resource efficiency
Your team keeps working on its own tasks while the audit programme stays on schedule, without training and qualifying internal auditors for every framework.
Cost predictability
Every audit is quoted in advance as a fixed price, based on scope, audit days and location. No open-ended consulting hours.
Standards and regulations audited
Audits can cover a single framework or several at the same time, so one visit serves more than one certification or market.
- ISO 13485:2016
- FDA QMSR (21 CFR Part 820)
- MDSAP (Australia, Brazil, Canada, Japan, USA)
- EU MDR 2017/745
- EU IVDR 2017/746
- ISO 14971:2019
- IEC 62304
- ISO 9001:2015
How an audit works
Scope and quote. You describe your company, products and the audit you need; you receive a scope and a fixed-price quote.
Audit plan. An audit plan with criteria, processes, sampling and agenda is agreed before the audit, on-site or remote.
Audit. Opening meeting, interviews, review of records and objective evidence, closing meeting with the findings.
Report. A written report with every finding graded and linked to the requirement, ready to be filed in your audit programme and to feed your CAPA process.
Who conducts the audits
Every audit is assigned to a qualified auditor with Notified Body or certification-body experience and a lead auditor qualification for the standard audited. The auditor is selected for the scope, the product technology and the language of the audit, and is independent of the activities audited.
Request an audit
Tell us what you need audited
Send a short description of your company, products, the audit type and the standards involved. You will receive a scope and a fixed-price quote.
Frequently asked questions
Are the audits conducted on-site or remotely?
Both. Each service can be delivered on-site at your premises or at your supplier, or remotely through document review and video sessions. Many engagements combine the two: remote document review first, then an on-site visit focused on the processes that need to be seen.
Which standards and regulations can be audited?
ISO 13485:2016, the FDA Quality Management System Regulation (21 CFR Part 820), MDSAP, EU MDR 2017/745, EU IVDR 2017/746, ISO 14971:2019, IEC 62304 and ISO 9001:2015. An audit can cover one framework or several at once, for example ISO 13485 together with MDSAP.
Does an internal audit by an external auditor satisfy ISO 13485 clause 8.2.4?
Yes. ISO 13485 requires internal audits to be planned and performed by auditors who do not audit their own work. Outsourcing the audit to an independent, qualified auditor meets that requirement and gives you the objectivity that a colleague auditing a neighbouring department cannot.
What do I receive at the end of the audit?
A written audit report with the scope, the audit criteria, the evidence sampled, and every finding graded and traceable to the requirement it refers to, plus a closing meeting where the findings are discussed. The report is written to be filed as a record of your audit programme.
How is the audit priced?
Each audit is quoted in advance as a fixed price based on scope, number of audit days and location, so the cost is known before the work starts. Send a short description of your company, products and the audit you need through the Request an audit button on this page to receive a quote.
Can the audit prepare us for a Notified Body or FDA inspection?
Yes. A mock FDA inspection or a pre-certification gap assessment follows the same approach as the real one, so the findings show where an inspector or a Notified Body auditor would focus, while there is still time to fix them.