ISO 13485 Consulting for Medical Device Manufacturers
ISO 13485 is the binding quality standard for medical device manufacturers. Sternberg Consulting guides you through gap analysis, QMS build-up, EU-MDR requirements and audit preparation — with a focus on regulatory certainty and practical processes.
Trusted by leading organisations
What is ISO 13485?
ISO 13485 is the industry-specific standard for quality management systems in medical technology. It builds on ISO 9001 but sets significantly stricter requirements for documentation, traceability, risk management and design control.
For medical device manufacturers, ISO 13485 is effectively mandatory: the EU-MDR requires a compliant QMS, and Notified Bodies expect an ISO 13485 certificate as evidence.
The standard is frequently combined with ISO 14971 (medical device risk management) and IEC 62304 (medical software).
Request a Free Consultation
I'll get back to you within 24 hours — no obligation, personal response.
Thank you!
I'll get back to you personally within 24 hours.
- ✓No obligation
- ✓BAFA funding may apply
- ✓Response within 24 hours
Personal delivery — from kickoff to audit.
I am Jonathan Sternberg, a certified ISO consultant and auditor. Every engagement is personally delivered by me — no junior team, no subcontractors.
My approach is remote-first and nationwide. You get clear communication, firm deadlines and a management system your team actually uses.
My verifiable lead auditor credentials: CQI IRCA PR328 (ISO 9001), ULN 606399, Course ID 1792 and CQI IRCA PR357 (ISO 45001), ULN 606399, Course ID 1885.
For certification projects, I coordinate with certification bodies operating under DAkkS, UKAS and ANAB accredited providers.
- ✓IRCA-recognised lead auditor courses: PR328 (ISO 9001) and PR357 (ISO 45001)
- ✓Works with accredited certification bodies, including DAkkS-, UKAS- and ANAB-accredited providers
- ✓100 % first-audit success rate
- ✓Based in Saxony, available nationwide
Who needs ISO 13485?
Medical device manufacturers
From Class I to Class III — EU-MDR requires a compliant QMS. ISO 13485 is the established route.
IVD manufacturers
IVDR (2022) has raised the bar. An ISO 13485 system is the foundation of every IVDR conformity.
Medical software & digital health
SaMD manufacturers need ISO 13485 plus IEC 62304 plus ISO 14971 — we build this as an integrated system.
Suppliers and contract manufacturers
Component, sterilisation and packaging service providers are regularly audited by OEMs against ISO 13485.
The route to ISO 13485 certification
From your first question to the certificate on the wall — and beyond.
Gap analysis & scoping
Comparison with ISO 13485, ISO 14971 and (for software) IEC 62304. Outcome: prioritised implementation plan with timeline.
Build risk management
Risk management file under ISO 14971 — the single most audited item. We get this right from the start.
QMS documentation
Procedures, work instructions, design controls, UDI management, post-market surveillance. Lean but complete.
Training & competence records
ISO 13485 requires documented qualification for every involved employee. We build the training matrix and evidence.
Internal audit
Full simulation of the certification audit. Open items are closed before the Notified Body arrives.
Certification audit
We accompany the external audit and support you on findings and corrective actions.
Why Sternberg Consulting for ISO 13485?
EU-MDR compliant from day 1
The QMS is built so it meets all MDR requirements directly — no retrofit needed.
Software & hardware experience
Whether SaMD, implant or Class I product — I know the specific challenges of each category.
Integrated ISO 14971 & IEC 62304
One integrated management system instead of three separate silos. Less effort, better consistency.
Intensive audit preparation
I simulate the audit fully — including role training for your staff.
Post-market processes
PMS and vigilance are set up as quality tools, not check-box tasks.
Fast first consultation
A concrete quote within 24 hours — no strings attached.
Up to 80 % of consulting costs reimbursed.
BAFA subsidises SME consulting via the "Förderung unternehmerischen Know-hows" programme. I handle the entire application.
"Energy and results convinced us. From first contact to Stage 2 audit in six weeks — only possible because Jonathan began the work even before the contract was signed."
Common questions.
How much does ISO 13485 consulting cost?
Depending on product class and complexity, €10,000 to €35,000. Software medical devices with IEC 62304 land at the higher end. Partial BAFA funding is possible depending on company size.
How long does certification take?
Typically 8 to 16 weeks. For complex software medical devices or full greenfield builds, longer. The gap analysis provides a reliable estimate.
Is ISO 13485 sufficient for EU-MDR?
ISO 13485 covers the MDR QMS requirements. In addition you need product-specific technical documentation and a clinical evaluation where applicable. We integrate both.
Who issues the certificate?
Medical device certification is done by accredited bodies such as TÜV SÜD, DEKRA, BSI or DQS Medical Devices. I coordinate vendor selection and gather quotes.
What is the difference to ISO 9001?
ISO 13485 is stricter on documentation, traceability, risk management and design controls. ISO 9001 principles like continuous improvement are deliberately more restrained in 13485 — stability trumps experimentation.
Is a separate audit required for software?
No, IEC 62304 is integrated into the ISO 13485 audit scope. The audit covers both standards in one visit.
How often do surveillance audits take place?
Annually by the Notified Body. Class II and III products have more intensive audits than Class I.
Let's talk.
Tell me where you stand and what you need. Within 24 hours you receive a first assessment and a concrete meeting proposal — free and without commitment.
- ✓Reply within 24 hours
- ✓Free first consultation, no strings attached
- ✓BAFA funding eligibility checked for you
Thank you!
Your enquiry has been received. You'll hear back from me personally within 24 hours.