MDSAP Experts in Germany
matched in minutes from 15,000 CVs with vetted, available specialists.Hire experts who handle MDSAP readiness, audit evidence, and quality system alignment for medical device organizations. They support the Medical Device Single Audit Program, supplier coordination, and CAPA follow-up, with fast, precise matching to vetted, available freelancers.
Meet FRATCH Experts in Germany, who have recently used MDSAP
Melanie S.
Last position:
Lead Quality / Regulatory at Confidential
Built and drove the implementation of an ISO 13485-aligned quality management system for a newly established medical-device manufacturer developing products for leading OEM customers. Led RA/QA strategy, QMS architecture, design-control setup, supplier-...
Isaac Udoh
Last position:
Global Head of Quality, Safety and Regulatory Affairs at RKW SE
Development and implementation of global quality, safety and regulatory affairs strategies.
Transformations in quality, safety, and regulatory affairs.
Lead RKW to deliver the quality promised to the customers and grow the business.
Lead RKW to successfully achieve the zero-safety incident journey.
Lead RKW to successfully achieve regulatory affairs compliance journey.
Envisioned, designed, and implemented a global quality, safety and regulatory affairs strategy for the RKW global business.
Successfully involved all 14 RKW sites in global quality and safety plan as lead site and/or roll out site.
Introduced safety, quality, master plan and safety A3 to all 14 RKW sites contributing to double digits €-Million EBITDA Y2024.
Included quality and safety into the company bonus system.
Led global workshops to build Root Cause Problem Solving capability across entire company (209 persons trained) and Job Safety Analysis capability (100 persons trained).
Introduced globally the top 3 quality defects/losses elimination using RCPS tool contributing to double digits €-Million EBITDA Y2024.
Regained confidence of top customers (Procter & Gamble, Essity, Ontex) via solid implementation of global quality strategy.
Reduced cost of claims by 35% (Y2024 vs Y2023).
Established a solid safety foundation and standards enabling continuous improvements in incident rate globally.
Monika Weber
Last position:
Quality Specialist at Nexans GmbH
- Implementation of a quality management system including creating all required process descriptions and work instructions for ISO 9001:2015 certification, as well as final planning and conducting audits
- Creating action catalogs for measures needed to comply with ISO 9001 and achieve the targeted certification
- Preparing documentation related to ISO 9001
- Developing training materials for employees and managers based on the QMH and the created documentation
- Recording results of external audits of departments (incoming goods, production, warehouse logistics, procurement and supplier management, outgoing goods, shipping) according to ISO 9001
- Preparing for and participating in certification audits
Nicole Melzer
Last position:
Interim Quality Manager, GMP and FDA Audit Preparation at Compliance Service Nord
With over 30 years of experience implementing and maintaining cGMP regulations, I support our clients in improving and streamlining their quality management (QM) processes. My passion for details, strategic and analytical mindset, and my creative, responsible team-player attitude set me apart. I prepare thorough GAP analyses and establish best-practice processes that meet guidelines - while remaining lean, efficient and practical.
Andreas Seidl
Last position:
Interim Head of Risk Management and Usability at Technolas Perfect Vision GmbH
- Lasers for ophthalmology
- Creation and maintenance of risk management files for ophthalmology devices
- Creation of a cybersecurity risk analysis according to MDCG (Medical Devices Coordination Group for notified bodies oversight, standardisation, market surveillance, international affairs, new technologies or clinical investigations) 2019/016, IEC 81001-5-1
- Testing software safety according to IEC 62304
- Conducting usability studies according to IEC 62366
- Process validation (process FMEA, IQ/OQ/PQ)
- Maintenance of SOPs, work instructions, etc. for risk management, usability, design control, and CAPA management according to ISO 13485
Achim Dohl
Last position:
Head of Operations at ZEISS Vision (Vision Technology Solution, VTS)
- Production, strategic sourcing, global 2nd level service, SCM, logistics, life cycle management, QA, launch prep
- Medical devices according to DIN ISO 13485, MDR, FDA & MDSAP for ophthalmology and opticians
- Bridged the management vacancy
- Design transfer for two R&D key projects
- Set up KPI dashboard
- Supply capability master plan 2023
- Established life cycle management
- Led and developed global service
- Coaching high potentials
- Built strategic sourcing
Lars Koste
Last position:
Temporary Head of Quality Management & Regulatory Affairs at Medical device manufacturer
- Temporary leadership of the Quality Management & Regulatory Affairs department
- Restructuring from 5 to 10+ internal and external staff
- Technical documentation
- Risk management (ISO 14971, FMEAs)
- Digitization projects
- Regulatory affairs
- Quality management
- Change management
- Clinical affairs (clinical and performance evaluations)
Discover over 15,000 top freelancers
Statistics of experts using MDSAP
Aggregated from the professional profiles of matched freelancers.
Experience
26 years
Position duration
1.9 years
Positions per freelancer
16
Top business areas
Project Management, Quality Assurance, Operations
Top industries
Healthcare, Manufacturing, Pharmaceutical
Certification focus areas
Quality Assurance, Audit, Project Management
Bachelor's degree or higher
100%
Master's degree or higher
57%
Doctorate
29%
Certifications per freelancer
6
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 Germany 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 Germany using MDSAP
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
MDSAP basics
MDSAP is the Medical Device Single Audit Program. It lets a company prepare one quality system for a single audit approach that can serve several regulators. Experts use it to align processes, records, and audit evidence for medical device operations.
What it covers
- Quality management system documentation
- Internal audit and CAPA evidence
- Supplier and traceability controls
- Management review and training records
- Audit readiness for MDSAP assessments
Where experts help
Strong specialists translate MDSAP requirements into clear work packages. They close gaps in procedures, records, and responsibilities before an audit starts. In Germany, they often support companies that work with export-focused medical device lines and need structured English documentation for global auditors.
Typical deliverables
A freelance expert may prepare gap assessments, document maps, audit checklists, and remediation plans. They also help teams answer auditor questions with consistent evidence. When needed, they coordinate with regulatory, quality, manufacturing, and supplier contacts so the audit file stays complete.
Skills that matter
- ISO 13485 and QMS documentation
- Regulatory audit preparation
- Risk-based process review
- CAPA, complaints, and change control
- Clear writing and cross-team coordination
Why companies bring one in
Companies usually need MDSAP help when an audit is near, when a QMS is changing, or when internal teams lack hands-on audit experience. A strong expert knows how to spot missing evidence early and reduce rework. They keep the focus on traceable records, not last-minute cleanup.
Frequently asked questions
Need clarity? These are the questions we hear most often about MDSAP.
MDSAP stands for Medical Device Single Audit Program. Companies use it to organize one quality system audit approach that supports multiple regulatory expectations at once. It is mainly relevant for medical device manufacturers that need strong documentation, traceability, and audit readiness.
MDSAP is not the same as ISO 13485, although the two are closely linked in practice. ISO 13485 is a quality management standard, while MDSAP adds a structured audit model with specific regulatory focus. A strong specialist understands both and can map the gap between the standard and audit evidence.
A good MDSAP specialist usually also knows CAPA, internal audits, document control, complaint handling, and risk-based thinking. In many projects, they also bring familiarity with supplier management and change control. Those skills matter because the audit outcome depends on the full quality system, not one file.
A company usually brings in MDSAP expertise when an audit is approaching, when internal procedures do not match the expected evidence, or when teams need a fresh review after findings. Outside help is also useful during QMS rollouts or major process changes. The goal is to reduce gaps before auditors see them.
Yes, MDSAP work can often be done remotely, especially for gap reviews, document checks, and audit preparation. On-site support is useful when a specialist needs to observe processes, meet production teams, or review records that are easier to assess in person. Many projects use a mix of both.
A strong MDSAP expert writes clearly, understands audit logic, and can turn vague process problems into concrete corrective actions. They should know how evidence flows through procedures, records, training, and CAPA. Good specialists also stay calm under audit pressure and keep teams focused on facts.
Ask for examples of gap assessments, audit preparation, or remediation work tied to medical device quality systems. A credible MDSAP freelancer can explain how they handled findings, mapped evidence, and supported teams through the audit cycle. Look for precise answers, not generic regulatory language.
A MDSAP freelancer working with German companies should be comfortable with structured documentation and cross-functional coordination. English is often needed for audit evidence and regulator-facing material, even when the local team speaks German. Clear communication and disciplined follow-up matter as much as technical knowledge.
The average hourly rate of freelancers in Germany who have used MDSAP in their recent projects is 131 €, which corresponds to a daily rate of about 1,047 € based on an 8-hour working day.
Of the freelancers in Germany who have used MDSAP in their recent projects, 100% hold at least a Bachelor's degree, 57% hold at least a Master's degree, and 29% hold a doctorate.
On average, freelancers in Germany who have used MDSAP in their recent projects have 26 years of professional experience, with a single engagement typically lasting around 1.9 years.
The most common languages among freelancers in Germany who have used MDSAP in their recent projects are German (100%), English (100%), and French (29%).
The most common industries among freelancers in Germany who have used MDSAP in their recent projects are Healthcare (86%), Manufacturing (71%), and Pharmaceutical (71%).
The most common business areas among freelancers in Germany who have used MDSAP in their recent projects are Project Management (100%), Quality Assurance (100%), and Operations (86%).
Main locations of FRATCH Experts, who have recently used MDSAP
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.
Berlin Hamburg Munich Cologne Frankfurt Stuttgart Dusseldorf Leipzig Dortmund Essen Bremen Dresden Hanover Nuremberg Request a free demo
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Philipp Thomaschewski
FRATCH CEO
