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.
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How close are you to ISO 13485?
Answer straightforward questions about regulatory roles, risk management, design, suppliers, traceability and CAPA. You receive an immediate initial assessment. If you upload existing documents, we review them free of charge and provide personal feedback on visible evidence and gaps.
About 10 minutes · Document upload optional
Plan your ISO 13485 meeting.
Tell me where you are with your medical-device QMS and what you want to achieve. I can then prepare the meeting around your situation.
- Choose the meeting focusSet the most important objective.
- Describe the objectiveChoose priorities or specific topics.
- Book meetingChoose a suitable appointment through Cal.com.
What is your ISO 13485 meeting about?
Choose the option that best describes your current situation.
Book meetingPersonal delivery — from kickoff to audit.
I am Jonathan Sternberg, a certified ISO consultant and auditor. I stay your direct point of contact from kickoff to audit.
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, CQI IRCA PR315 (ISO 14001), ULN 606399, Course ID 2067 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), PR315 (ISO 14001) 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
Medical device manufacturers
From Class I to Class III — EU-MDR requires a compliant QMS. ISO 13485 is the established route.
Photonics and precision suppliers
Optical, electronic and precision components for medical devices need controlled processes and traceability.
Medical software and digital health
SaMD manufacturers need ISO 13485 plus IEC 62304 and ISO 14971 — as an integrated system.
Suppliers and contract manufacturers
Component, manufacturing and packaging 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.
- 1
Gap analysis & scoping
Comparison with ISO 13485, ISO 14971 and (for software) IEC 62304. Outcome: prioritised implementation plan with timeline.
- 2
Build risk management
Risk management file under ISO 14971 — the single most audited item. We get this right from the start.
- 3
QMS documentation
Procedures, work instructions, design controls, UDI management, post-market surveillance. Lean but complete.
- 4
Training & competence records
ISO 13485 requires documented qualification for every involved employee. We build the training matrix and evidence.
- 5
Internal audit
Full simulation of the certification audit. Open items are closed before the Notified Body arrives.
- 6
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.
Book a meeting
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
- ✓Personal assessment of your project
- ✓Funding eligibility checked on request