Quality management and regulatory affairs for SMEs
Meet the standards without drowning in them.
Small and medium-sized companies face the same requirements as large corporations, with a fraction of the resources. I build systems that hold up under inspection and still fit how the company actually works.
Request a first call Free, 30 minutes, no obligation
German and English. Remote or on site in eastern Switzerland.
Frameworks I work with
- ISO 9001 Quality management, any industry
- ISO 13485 Quality management for medical devices
- IATF 16949 Quality management in automotive supply
- ISO 27001 Information security
- EU 2017/745 Medical Device Regulation MDR
- EU 2017/746 In Vitro Diagnostic Regulation IVDR
- 21 CFR 820 FDA Quality System Regulation
- 510(k) US market clearance
- EU 2024/1689 AI Act
- REACH / RoHS Product and material compliance
Several frameworks at once is the norm, not the exception. One integrated system costs less than three parallel ones.
Services
Two disciplines that belong together: a system that works, and documentation that carries market access.
Quality management
- Building a QMS
- From a blank page to certification readiness: process landscape, document control, metrics. Lean enough that people actually use it.
- Audits
- Internal audits, preparation for certification and customer audits, support during the audit and closure of findings.
- Supplier quality
- Qualification, evaluation, supplier audits and quality agreements, including international supply chains.
- CAPA and complaints
- Root cause analysis that deserves the name, effective actions, and evidence of effectiveness that holds up in an audit.
Regulatory affairs
- Technical documentation
- Built or reworked to MDR and IVDR, including the risk management file, clinical evaluation and post-market plans.
- Market authorisation
- Market access in the EU, Switzerland and the US. Strategy, submission and support through to clearance, including 510(k).
- PRRC
- Acting as the person responsible for regulatory compliance under MDR Article 15.
- Swiss authorised representative
- CH-REP for manufacturers without a Swiss establishment, including Swissmedic registration and importer obligations.
How it works
Four steps. After the first one you know where you stand, even if we never work together.
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1
First call
Thirty minutes, free. You describe the situation, I tell you what is coming and whether I am the right person for it.
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2
Assessment
I review what exists and what is missing, and deliver a gap analysis with effort estimate and sequence.
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3
Implementation
We close the gaps, as a project, under a retainer, or by coaching your own team.
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4
Evidence
The result has to survive the audit and the authority. That is the measure, not the binder delivered.
Profile
Sixteen years of quality management and regulatory affairs in medical devices, pharma and healthcare.
I have built quality systems, sat on both sides of the audit table and rolled out processes internationally. So I know both failure modes: the system that satisfies the standard but nobody uses, and the system that people live by but that does not survive inspection. Both are expensive. The work lies in between.
- Master of Engineering with a focus on quality management
- Experience across medical devices, pharma, automotive supply and industry
- Built and led audit, QA and CAPA teams
- Consulting in German and English
Where do you stand today?
Whether it is a first certification, an audit on the horizon or a product heading into a new market: in thirty minutes we establish what is needed and roughly what it costs.