ISO 13485 Experts in Switzerland
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Meet FRATCH Experts in Switzerland, who have recently used ISO 13485
Dieudonné M.
Last position:
External Auditor at SGS Switzerland
- QMS development according to international standards
- ISO 9001 & ISO 13485 certification audits
- Environmental management audits according to ISO 14001 (training & application)
- Conducting audits in the DACH region (remote & on-site)
- Remote & on-site audit experience (EU, DACH, APAC)
Gregory R.
Last position:
Site Director and Turnaround (interim) at Dalli – De Klok BV
- Site leadership – 230 employees; €150M
- Turnaround and transformation of the site
- Introduction of Lean principles based on IWS (P&G)
- Increase of OEE by 20%
- Stabilization of delivery performance and elimination of out-of-stock situations, working closely with customers
- Close collaboration with the group to ensure the site was used to its full capacity
Oliver W.
Last position:
Specialist Planner / Cleanroom Planning Lead at Major Aircraft Manufacturer
- Start-up and commissioning of the cleanroom
- Certification of the cleanroom
Jürgen S.
Last position:
Manager Manufacturing Operations USP at Thermo Fisher Scientific
- Liquida, aseptic/sterile, fill & finish, solida in production & packaging
- CAPEX/Greenfield, 5kL SUT Owner, CVQ, runs/SCM/SCORE, SFM, KPI, CAD, CQV, MSAT, trainings, audits, EHS
- Organization, construction, sterile production, operations, packaging, PPQ, Op-readiness, RM, audits, documentation authoring
Hans S.
Last position:
Interim Manager, Consultant, Facilitator at Business Excellence Services GmbH
Interim manager, consultant, facilitator
Project management with focus on trouble shooting & customer care and/or product development/reengineering; regulatory management
Supply chain; risk and quality management; people management
Experienced within medical device; aerospace; packaging; small- & large equipment; optical- & electrical-systems; metal & plastics; free auditor
Since 2016, working for various accredited organizations as a freelance auditor regarding systems according to ISO 13485 and ISO 9001
2023-2024: Medical device product development, supply-chain and regulatory set-up with regard to a medical device re-engineering/launch and manufacturing
2023-2024: Project trouble shooter & customer care in the European aerospace industry within precision optics systems manufacturing; project risk and validation management including software validation
2022: Validation (FMEA, IQ OQ, PQ) management assigned with design and process risk assessment of complex electrical (IEC60601-1) mechatronics robots for MDR approval following ISO 14971
2022: Interim head of QM in aluminum-foil deep drawing process improvement; people and international Nespresso supplier quality management
2021-2022: Cytiva Cell Therapy greenfield project; assigned with design and implementation support of a certification, validation, GMP commissioning strategy for the technical infrastructure, e.g., clean rooms
2020-2021: Interim QA-Leader in Denmark assigned with the software release, manufacturing and distribution of Class IIb laser equipment for Candela, including international notified body and manufacturing transfer project
2020: Quality support and interim quality management for a manufacturer in the IVD test equipment supply chain and dialysis supplies in Bavaria
2018-2020: Expert/SME in Q-Management/Q-Engineering for orthopedic and arthroplasty device and tool production: turning, milling, cleaning, surface treatment and sterile packaging
2017: Re-engineering of the Medela product development process regarding cGMP 21CFR820.30/ISO 13485:2016 and MDR design control requirements for soft and hardware design regarding Class IIb pumps
2017: MDSAP preparation support and mock-audit coaching
2016: Interim senior QE-Expert for Maquet extracorporeal circulation devices manufacturing as ISO 14971 risk and change management expert in a Roche CAPA remediation and compliance project of IVD blood analyzers/gas sensor production
2016-2017: Orthopedic and arthroplasty implants design history file (DHF) review regarding compliance to 21 CFR 820.30 design control requirements
2015: Assigned by Novartis with design control for a new parenteral drug delivery system; manufacturability assessments during design evaluation; assessing potential plastic injection molding and/or high-volume assembly contractors in Europe and the US
2014: Assessing/auditing metallurgy process validation (IQ/OQ/PQ) of Zimmer contract manufacturers around Europe for FDA audit readiness; Depuy-Synthes subject matter expert (SME)
2013-2014: CAPA-8D process reengineering and setting in place/training new EtQ software tools; coaching of project and product managers in working through individual CAPAs; remediation of global legacy CAPAs; supporting complaint and field action (FSCA) management
2012-2013: QA/RA Manager at Sias AG for in vitro diagnostics (IVD) liquid handling robots manufacturing; led small team for electrical safety CE/CB scheme product approvals; QMS, change and CAPA management
2011-2012: Site Quality Manager at Medtronic for drug eluting balloon and Nitinol stent-catheter manufacturing; quality operations including Q-engineering and control; led 15 direct and indirect reports
2009-2010: Supported quality initiatives in medical device industry; assessments and audits for manufacturers and suppliers as a consultant of Business Excellence Services
Andrew L.
Last position:
Service Manager - Testing at Takeda Pharmaceutical International AG
- Managing the Testing services for the Global IT Testing Centre of Excellence (TCoE) team, which is responsible for managing and supporting the Product & Project Testing Workstreams on various Regional Projects, especially in Pharmacovigilance, Digital Supply Chain, Clinical Practice and R&D, etc.
- Managing Client relationships, escalations and continuing to grow the project services globally, while also driving the testing efforts on Takeda’s AI, DevOps, Agile, and Digital projects.
- Led the implementation of a Quality Management System (QMS), ensuring compliance with GCP, GMP, and Swiss and EU regulations, resulting in a huge improvement in audit readiness.
- Overseeing projects for systems including ERP, EDGE, SAP ECC, SAP Transportation Management, S/4 HANA migration etc.
- Led an AI/ML PoC for AI implementation.
- Led a cross-functional team to ensure compliance with MDR, FDA regulatory guidelines and achieved successful project deliveries.
- Led and managed change management and communication for TCoE, keeping the Takeda organisation informed of change communication and practices, including presentations to various stakeholders.
- Ensuring TCoE outsource vendor resources adhere to regulatory, compliance and quality system standards and practices for GxP & non-GxP System Development Life Cycle (SDLC) including aSDLC and TCoE Global Standards.
- Translated the product vision, strategy and requirements into backlog items, which were prioritised based on potential business impact and customer value.
Holger L.
Last position:
Regulatory Affairs Manager at Andreas Hettich GmbH
Martin A.
Last position:
Martin Aicher
Main areas of activity ⋅ Martin Aicher
Areas of expertise
Medical technology
Sensor technology
Technical optics
Mechatronics
Microsystems technology
Biocompatible materials
Implants and endoprosthetics
Project management
Quality management IPMA
Regulatory affairs
Education
Dr.-Ing. Medical Technology
M.Sc. Medical Technology
Dipl. Ing. (FH) Medical Technology
Surgical mechanic, precision mechanic
Methodical product development
26 years of research, development, verification and agile product development
5 years of hands-on manufacturing of micromechanical instruments and implants
Projects
Development and verification of technical optics
Microscopy
Endoscopy
Immersion optical systems
Optical sensors
Light guides
Device development — medical electronics, active medical devices
Electromagnetic therapy devices for microcirculation of blood vessels
Electric drives, precision mechanics motors
Embedded devices, Medicine 4.0 / Industry 4.0
Feasibility studies, prototype design, electromechanical, chemical and hydrodynamic characterization up to series maturity
Structural integration of motors for pump systems
Integration of motors for catheter drives
Implantable drive systems with motors
Bone saws with Maxon motors
Osteosynthesis implant (bone implant) with linear drive
Electromagnetic therapy devices for microcirculation of blood vessels
Gold and platinum substitution for electrodes
Electrochemical impedance spectroscopy (EIS)
Characterization and development of battery cells and Li-ion batteries
Biocompatible materials: stainless steel, titanium, nitinol, polymers, ceramics, composites
Vacuum device with pumps for wound healing
Braided tubes (reinforced hoses)
Shaft instruments and trocars
Surgical instruments, minimally invasive instruments (MIC)
Analytical instruments, sensors and fluid preparation
Monitoring systems
In vivo diagnostics (IVD)
Inline measurement systems for monitoring and analytical devices
Feasibility studies, prototype design, electrochemical and hydrodynamic characterization up to series maturity
Electrochemical deionization (EDI) as a monitor
Membrane technology
Measurement method and control of carbide saturation in cooling water
pH sensor
Optical sensors with laser diodes and LEDs
Dissolved O2 sensor
CO2 sensors
Ion-selective sensor (ISE)
Conductivity sensors
Turbidity sensor according to ISO 7027
Biosensors
Flow and pressure sensors
Gold and platinum substitution for electrodes
Electrochemical impedance spectroscopy (EIS)
Biocompatible materials: stainless steel, titanium, nitinol, polymers, ceramics, composites
Design of plastic injection-molded components and housings
Calculation and design of fluid channels
Design of metal die-cast components
Design of sheet metal parts
Implants and prostheses
Endoprosthetics: knee and hip endoprostheses
Bypass implants
Nitinol stents
Bone plates
Dental implants
Precision meshes
Instruments for medical technology
Angioplasty: PTCA percutaneous transluminal coronary angioplasty with balloon catheter
Catheter system as minimally invasive heart pump
EN ISO 10555-4: intravascular catheters
Braided tubes (reinforced hoses through precision meshes)
Thrombectomy with rotablation catheter
Trocars
Surgical instruments, minimally invasive instruments (MIC)
Endoscopes ISO 8600-1, EN 60601-2-18, EN 62471
Regulatory affairs for medical devices
CE for Europe (Class II and III), EU Medical Device Regulation 2017/745 (MDR)
EU Regulation 2017/746 for in vitro diagnostics (IVDR)
Ensuring complete documentation according to current regulatory requirements
FDA registration and approval 510(k), PMN, PMA, Class II, III
Design History Files (DHF), Device Master Record (DMR), Device History Record (DHR)
Internal and external audits
FDA and CE audits
Mock audits
Requirement engineering, user requirement specifications, functional requirement specifications
Quality management and relevant standards for medical technology
EN ISO 9001:2015
EN ISO 13485:2021
USA FDA 21 CFR 820 Quality Management System
FDA 21 CFR §§ 803, 806, 807, 830
In vitro diagnostics (IVD, IVDR) FDA 21 CFR §§ 600, 610, 660
USA FDA risk management for medical devices DIN EN ISO 14971:2019
P-FMEA for production
Usability of medical devices EN 62366-1:2021
CAPA (Corrective and preventive action) and GMP
Medical electrical equipment EN 60601-1:2013
EMC for medical devices DIN EN 60601-1-2:2022
Medical device software EN 62304:2018
Cell culture in cleanroom with different cell lines for biocompatibility testing of polymers and alloys
Biological evaluation of medical devices EN ISO 10993
Clinical investigation of medical devices ISO 14155
Manufacturing technology and processes
Process qualification and validation
Injection molding technology
CNC micromechanical manufacturing
Microsystems technology, printed circuit boards (PCB)
Joining technologies: laser welding of titanium, stainless steel, plastics as well as gluing and ultrasonic welding
Evaluation, setup and qualification of equipment
Thin film and surface technology
Coating of implants and tribological surfaces with chemical vapor deposition (CVD) and physical vapor deposition (PVD), sputtering of precious metals, stainless steels, nitinol, titanium alloys, polymers and ceramics
Plasma technology for functional coatings: hydrophilic and hydrophobic surfaces
Nanotechnology: surface functionalization: self-assembled monolayers (SAM)
Product Life Cycle Management
Finite element method
ANSYS FEM
Structural mechanics, statics
Fluid mechanics, flow simulations
Electrical engineering, electromagnetic fields
Characterization and testing of microelectronics
PCB (printed circuit board)
Sensor technology
Microcontrollers
CAN bus: ISO 11898, SAE
Control and data management with LabVIEW and Matlab
Programming language
Python 3.14
CAD
Autodesk Inventor
Pro/ENGINEER, PTC Creo Parametric
SolidWorks
Siemens NX
Solid Edge
Standards-compliant technical drawings
Endurance tests, mechanical, fluid mechanical, electrical and chemical characterization
Verification, V-Model, End of Line (EOL) testing
Writing work instructions for production, English regulatory documents and scientific articles
Support of clinical studies
Data processing, digital data management and statistics
Professional handling of Microsoft Office applications: PowerPoint, Word and macro programming for Excel
© 2026 M. Aicher
Thomas H.
Last position:
Sales Partner at SourceWeb Group
- Consulting and sales in cyber security
Sabrina L.
Last position:
Subject Matter Expert of the INOS Platform «Excellence in Supply Chains» at INOS.SWISS
Discover over 15,000 top freelancers
Statistics of experts using ISO 13485
Aggregated from the professional profiles of matched freelancers.
Experience
27 years
Position duration
3.3 years
Positions per freelancer
12
Top business areas
Quality Assurance, Project Management, Audit
Top industries
Healthcare, Manufacturing, Pharmaceutical
Certification focus areas
Quality Assurance, Audit, Information Technology
Bachelor's degree or higher
89%
Master's degree or higher
78%
Doctorate
22%
Certifications per freelancer
4
Most common languages
German, English, French
Speak two or more languages
100%
Based on our profile pool as of 29 Oct 2026.
Daily rate distribution
The chart shows how the daily rates of experts in this technology in Switzerland are distributed, based on recent contracts on our platform. Each bar covers a rate range — its height shows the share of experts charging within that range.
Average rates of experts in Switzerland using ISO 13485
Rates are based on recent contracts and do not include FRATCH margin.
The average daily rate is the mean of all daily rates from recent contracts of comparable freelancers on our platform.
The median daily rate is the middle value of all daily rates — half of comparable freelancers charge less, half charge more. Unlike the average, it is barely affected by outliers.
Calculated based on our freelancers’ daily rates as of 29 Oct 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
ISO 13485 experts industry focus
See which industries our matched freelancers work in most often — every figure is calculated live from the freelancers on FRATCH.
- Healthcare (90%)
- Manufacturing (80%)
- Pharmaceutical (50%)
- Aerospace and Defense (30%)
- Biotechnology (30%)
- Banking and Finance (30%)
- Professional Services (30%)
- Energy (20%)
Please note that freelancers can work across multiple industries, so percentages overlap.
About the technology
Quality system foundation
ISO 13485 is the international quality management standard for organizations involved in medical devices and related services. It focuses on consistent product quality, patient safety, risk-based controls and documented processes across the full product lifecycle. The standard applies to manufacturers, suppliers and service providers supporting regulated medical device work.
Medical device lifecycle
Companies use ISO 13485 to control design, development, production, installation, servicing and post-market activities. Its requirements help connect technical decisions with traceable records, approved procedures and corrective action. The framework can support products ranging from diagnostic equipment and software to implants, consumables and laboratory devices.
Compliance ecosystem
Professionals work across quality, regulatory and operational functions. Common tools and related frameworks include:
- Quality management systems and controlled documentation
- Risk management aligned with ISO 14971
- Design controls, validation and verification records
- Supplier qualification and change control
- CAPA, complaint handling and post-market surveillance
When expertise matters
Freelance expertise is useful when a company is building a quality system, preparing for certification or addressing audit findings. It also helps during product transfers, supplier changes, remediation projects and expansion into new markets. In Switzerland, specialists often support medtech, diagnostics and life sciences organizations while coordinating remote and on-site work with internal teams and external auditors.
Practical project outcomes
A strong engagement produces clear, usable evidence rather than paperwork alone. Typical deliverables include quality manuals, standard operating procedures, process maps, risk files, design history documentation, audit plans and CAPA records. Experts should adapt the system to the company’s products, size, supply chain and regulatory responsibilities.
What strong experts bring
Look for professionals who can interpret clauses in context, ask precise questions and translate requirements into workable processes. They should understand the relationship between ISO 13485, ISO 14971, applicable regulatory submissions and electronic quality systems. Strong communication matters when teams work across Switzerland, different languages, remote locations and multiple organizational functions.
Frequently asked questions
The facts hiring teams ask for most often when it comes to ISO 13485.
ISO 13485 is used to establish and maintain a quality management system for medical devices and related services. It helps organizations control design, production, suppliers, records, complaints, changes and corrective actions in a consistent, auditable way.
ISO 13485 is tailored to medical device quality and regulatory expectations, while ISO 9001 applies more broadly across industries. ISO 13485 places stronger emphasis on documented controls, product safety, risk management, traceability and maintaining compliance throughout the device lifecycle.
A capable ISO 13485 specialist often brings knowledge of ISO 14971 risk management, design controls, validation, supplier quality and post-market surveillance. Familiarity with electronic quality management systems and the regulatory requirements of the target markets is also valuable.
The right level of ISO 13485 experience depends on the scope, product risk, company maturity and audit timeline. A focused procedure update may need targeted support, while certification preparation, remediation or a new quality system calls for a professional who has managed comparable end-to-end work.
Much of ISO 13485 work can be completed remotely, including document review, process design, training and audit preparation. On-site sessions may still help with production observations, interviews, supplier assessments or implementation in Swiss facilities, so agree early on which activities require physical presence.
Ask how the ISO 13485 specialist has handled audits, CAPA, risk files, design controls and changes in a comparable device environment. Review the reasoning behind their proposed processes, not only the documents they produce, and check whether teams can actually follow the resulting system.
ISO 13485 certification demonstrates conformity with the standard, but it does not by itself authorize sales in every market. Market access can require additional regulatory submissions, local representation, product evidence and surveillance obligations, which the specialist should map against the company’s intended destinations.
An ISO 13485 professional should communicate clearly with quality, regulatory, production and product teams. For work in Switzerland, confirm the languages needed for procedures, training and audit interactions, as well as the balance between remote collaboration and visits to local sites.
The average hourly rate of freelancers in Switzerland who have used ISO 13485 in their recent projects is 122 €, which corresponds to a daily rate of about 974 € based on an 8-hour working day.
Of the freelancers in Switzerland who have used ISO 13485 in their recent projects, 89% hold at least a Bachelor's degree, 78% hold at least a Master's degree, and 22% hold a doctorate.
On average, freelancers in Switzerland who have used ISO 13485 in their recent projects have 27 years of professional experience, with a single engagement typically lasting around 3.3 years.
The most common languages among freelancers in Switzerland who have used ISO 13485 in their recent projects are German (100%), English (100%), and French (50%).
The most common industries among freelancers in Switzerland who have used ISO 13485 in their recent projects are Healthcare (90%), Manufacturing (80%), and Pharmaceutical (50%).
The most common business areas among freelancers in Switzerland who have used ISO 13485 in their recent projects are Quality Assurance (90%), Project Management (70%), and Audit (50%).
Main locations of FRATCH Experts, who have recently used ISO 13485
Our freelancers and interim experts are at home across the DACH region — available on-site in the major business hubs or fully remote. Choose a location to discover matched specialists, local market insights and up-to-date availability.
Countries:
Zurich Geneva Basel Bern Request a free demo
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