Team Elexes 
Internal audits that connect requirements, procedures and evidence.
Medical Device Compliance Audits
Elexes conducts medical device internal audits to help manufacturers identify QMS gaps, assess implementation and prepare for external audits or regulatory inspections. We scope each audit around your devices, activities, sites and target markets.
Our audit services include risk-based internal audits, FDA QMSR audits, ISO 13485 audits, MDSAP readiness assessments, and targeted reviews of medical device quality and manufacturing processes.
When should you schedule an internal audit?
⦿ Your planned internal audit is due.
⦿ A certification, surveillance, recertification or MDSAP audit is approaching.
⦿ You are preparing for a regulatory inspection.
⦿ Products, suppliers, sites or quality processes have changed.
⦿ Previous findings or quality issues need follow-up.
Our medical device internal audit services
FDA QMSR Internal Audit & Mock Audit
Evaluate QMSR implementation through targeted audits of manufacturing controls, process validation, supplier oversight, and CAPA. Identify compliance and evidence gaps to strengthen FDA inspection readiness.
ISO 13485 audit
Assess QMS processes and implementation against applicable ISO 13485 requirements. Connect findings with your existing ISO 13485 compliance programme.
Regulatory audit and inspection preparation
Ensure that the applicable market requirements are part of your criteria for auditing and sampling evidence that supports your regulatory responsibilities and quality decisions.
MDSAP audit readiness
Prepare for a formal MDSAP audit through an internal assessment of applicable QMS processes and participating-country requirements.
Targeted process and supplier audits
Focus on selected areas such as design and development, supplier controls, production, validation, complaints or CAPA. Supplier audits are scoped separately around outsourced activities and associated risks.
Under FDA QMSR, internal quality audit, supplier audit, and management review reports may be examined during inspections. A proactive assessment helps identify gaps in documented findings, corrective actions, and supporting evidence before regulatory scrutiny.
Internal audit coverage across key markets
We select applicable criteria for your devices and organizational role:
⦿ United States (FDA): Assess compliance with QMSR requirements under 21 CFR Part 820, incorporating ISO 13485:2016, through risk-based audits of quality-system processes, manufacturing controls, supplier oversight, CAPA, and objective evidence readiness.
⦿ European Union: Assess relevant QMS interfaces under the EU MDR or IVDR, including risk management, technical documentation, post-market surveillance and vigilance.
⦿ United Kingdom (MHRA): Review applicable Great Britain requirements, including post-market surveillance. Northern Ireland is assessed against the applicable EU MDR/IVDR framework.
⦿ Canada (Health Canada): Identify the requirements as per Medical Devices Regulations, and MDSAP readiness Assessment. For class II to class IV medical device manufacturers, the need for MDSAP QMS certification is common; class I and importers/distributors will be handled differently.
⦿ Japan (MHLW/PMDA): Assess applicable Ministerial Ordinance No. 169 requirements, including Japan-specific additions to the ISO 13485 framework.
⦿ Australia (TGA): Review applicable Australian QMS and post-market obligations, including relevant MDSAP country requirements.
An internal audit supports readiness. It does not replace a regulator inspection, certification audit, notified body assessment or formal MDSAP audit by a recognized auditing organization.
Our internal audit process
⦿ Define the scope: Decide on locations, procedures, markets, criteria for audits, and reporting format.
⦿ Plan the audit: Select audit trails based on process importance, changes and previous results.
⦿ Examine implementation: Interview process owners, sample records and observe activities where needed.
⦿ Report findings: Provide evidence-based findings linked to applicable requirements and discuss the results.
⦿ Review follow-up: Assess corrections, corrective actions and effectiveness evidence where included.
What you receive
⦿ An agreed audit plan and criteria.
⦿ An audit report with sampled evidence and findings.
⦿ A findings tracker for ownership and follow-up.
⦿ A closing discussion on results and next steps.
Remediation and follow-up reviews are defined separately in the proposal. Where needed, continue with our quality management system support.
Why Elexes?
⦿ Evidence-led reviews: Examine whether procedures match records and actual practice.
⦿ Relevant scope: Focus on applicable processes, product risks and market requirements.
⦿ Actionable findings: State the requirement, supporting evidence and identified gap clearly.
Explore our guide to complaint file audit readiness.
FAQs
Frequently Asked Questions!
Yes. External auditors can support your internal audit programme. Your organization retains responsibility for the programme, follow-up and QMS effectiveness.
Yes, but provided that scope and criteria include market requirements. Common QMS structure does not preclude specific national requirements.
No. An internal assessment can support MDSAP readiness. A recognized auditing organization conducts the formal MDSAP audit.
Duration and fees depend on sites, processes, devices, markets and delivery format.
Plan your next internal audit
Share your devices, sites, target markets and preferred audit date. We will discuss the scope, delivery format and next steps.
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Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms
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Diane Bryant
CEO Novasignal, Los Angeles
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.
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President ViDava, Florida
“Professional and easy to work with! They expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice.
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Linda Pan
Sr. Exe Treedental, Hong Kong
“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step.
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Joshua Mink
Manager Outset Medical, California
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Michal Depa
CTO Jana Care, Massachusetts
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly.
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Philip McFerran
MD Blackrock Pharma, England
“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations.
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VP Regulatory AliveCor, California
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Elizabeth W
Owner Liz Inc., Arizona
“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time.
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CEO Radformation, New York
“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation!
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