ISO 13485 Experts in Switzerland
in minutes from over 15,000 CVs with the power of AIHire experts who know ISO 13485, medical device quality management, and audit-ready documentation. They support QMS design, supplier control, validation work, and remediation for regulated products in Switzerland, matched fast with vetted, available freelancers.
Meet FRATCH Experts in Switzerland, who have recently used ISO 13485
Gregory Rump
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
Dieudonné Mbarga
Last position:
External Auditor at SGS Switzerland
- QMS setup according to international standards
- ISO 9001 and ISO 13485 certification audits
- Environmental management audits according to ISO 14001 (training and application)
- Conducting audits in the DACH region (remote and on-site)
- Remote and on-site audit experience (EU, DACH, APAC)
Oliver Wulf
Last position:
Specialist Planner / Cleanroom Planning Lead at Major Aircraft Manufacturer
- Start-up and commissioning of the cleanroom
- Certification of the cleanroom
Hans Spichiger
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 Longe
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 Landau
Last position:
Regulatory Affairs Manager at Andreas Hettich GmbH
Martin Aicher
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 Höhle
Last position:
Sales Partner at SourceWeb Group
- Consulting and sales in cyber security
Sabrina Landolt
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
3.5 years
Positions per freelancer
11
Top business areas
Quality Assurance, Project Management, Product Development
Top industries
Healthcare, Manufacturing, Pharmaceutical
Certification focus areas
Quality Assurance, Information Technology, Audit
Bachelor's degree or higher
88%
Master's degree or higher
75%
Doctorate
13%
Certifications per freelancer
4
Most common languages
German, English, French
Speak two or more languages
100%
Based on our profile pool as of 30 Aug 2026.
Daily rate distribution
The chart shows how the daily rates of freelancers in this technology in Switzerland are distributed, based on recent contracts on our platform. Each bar covers a rate range — its height shows how many freelancers charge 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 30 Aug 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
About the technology
What it covers
ISO 13485 is the quality management standard for medical devices and related services. It is used to build controlled processes, traceable records, and consistent product quality across the lifecycle. Teams often search for ISO 13485:2016, EN ISO 13485, or medical device QMS support when they need practical help, not theory.
Where it fits
- Quality management system setup and cleanup
- Document control, risk files, and CAPA support
- Supplier qualification and change control
- Internal audits and management review prep
- Design transfer and validation evidence
Why companies hire help
Companies bring in freelance specialists when a submission, audit, or remediation effort needs focused attention. ISO 13485 work is common in medtech, diagnostics, contract manufacturing, and software-connected devices. In Switzerland, teams often need experts who can work with local stakeholders and keep English documentation clear.
Strong skills
Good professionals know how to connect the standard to daily work. They read procedures critically, spot gaps in records, and turn requirements into simple controls. They also understand how ISO 13485 links with risk management, supplier management, and product lifecycle documentation.
Common deliverables
A strong engagement can include a gap assessment, a QMS update plan, SOP drafting, audit support, or remediation tracking. For software or connected devices, experts may also help align verification, validation, and traceability evidence. The work should leave the team with documents that are usable, not just compliant on paper.
When to look for an expert
- An audit finding needs closure
- A new device program needs a compliant QMS
- Procedures do not match actual practice
- A supplier or contract manufacturer needs tighter control
- The team needs temporary leadership for a quality project
Frequently asked questions
The facts hiring teams ask for most often when it comes to ISO 13485.
ISO 13485 defines the quality management requirements for medical device organizations and related services. Companies use it to control design, production, documentation, supplier activity, and post-market processes. It is the standard behind a well-run medical device QMS.
ISO 13485 is more specific and more demanding for regulated medical device work than ISO 9001. ISO 9001 is a general quality standard, while ISO 13485 focuses on risk control, traceability, documentation, and regulatory readiness. If a project touches medical devices, ISO 13485 is usually the better fit.
A strong ISO 13485 specialist is often brought in for QMS setup, gap assessments, remediation, supplier controls, or audit preparation. They are also useful when a team needs help with design transfer, validation records, or CAPA improvement. These projects usually need someone who can turn the standard into practical process changes.
A good ISO 13485 professional usually also understands risk management, internal auditing, document control, and corrective action. Familiarity with design controls, supplier quality, and validation evidence is a major advantage. In medtech, they should also know how to write clear procedures that teams will actually follow.
The right level depends on the task, but ISO 13485 work rarely benefits from a generalist alone. Simple document cleanup may need a focused specialist, while audit recovery or QMS redesign needs someone who has handled similar regulated environments before. The key is proven work on real quality systems, not just familiarity with the standard.
Much of the ISO 13485 work can be done remotely, especially document reviews, gap assessments, and procedure drafting. On-site time helps when the specialist needs to observe production, interview teams, or review how the process works in practice. In Switzerland, many projects use a mix of both.
Look for clear examples of audit support, QMS improvement, and practical document writing around ISO 13485. A strong expert explains gaps plainly, connects findings to risk, and leaves behind usable records and procedures. Good signs are structured communication, familiarity with regulated product workflows, and a calm approach to remediation.
ISO 13485 is the core standard name, while EN ISO 13485 is the European adoption and ISO 13485:2016 is the current edition people often reference in search. The terms are related, but project needs usually depend on the applicable market and regulatory context. A good specialist will know which version matters for the work at hand.
The average hourly rate of freelancers in Switzerland who have used ISO 13485 in their recent projects is 118 €, which corresponds to a daily rate of about 941 € based on an 8-hour working day.
Of the freelancers in Switzerland who have used ISO 13485 in their recent projects, 88% hold at least a Bachelor's degree, 75% hold at least a Master's degree, and 13% 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 3.5 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 (56%).
The most common industries among freelancers in Switzerland who have used ISO 13485 in their recent projects are Healthcare (89%), Manufacturing (78%), and Pharmaceutical (44%).
The most common business areas among freelancers in Switzerland who have used ISO 13485 in their recent projects are Quality Assurance (89%), Project Management (67%), and Product Development (56%).
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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