MDSAP Experts in Germany
with precise AI matching and vetted, available freelancersHire experts who prepare audit-ready quality systems, coordinate regulatory submissions and manage corrective actions across medical device markets. Get fast, precise matching with vetted, available freelancers who understand MDSAP requirements and German industry processes.
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-...
Andreas S.
Last position:
Consulting on quality management and regulatory affairs at Curevius GmbH
Manufacturer of medical devices
- Creation and further development of quality management systems according to EN ISO 13485
- Gap analysis of existing quality management systems according to ISO 13485
- Consulting and support in customer projects in the field of quality management and
- Proof of regulatory compliance for medical devices of all risk classes
- Preparation of technical documentation according to MDR
- Gap analysis of the risk management file according to ISO 14971:2019
Isaac U.
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 W.
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 M.
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.
Achim D.
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 K.
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
27 years
Position duration
1.9 years
Positions per freelancer
16
Top business areas
Project Management, Quality Assurance, Supply Chain Management
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 29 Oct 2026.
Daily rate distribution
The chart shows how the daily rates of experts in this technology in Germany 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 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 29 Oct 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
MDSAP experts industry focus
See which industries our matched freelancers work in most often — every figure is calculated live from the freelancers on FRATCH.
- Healthcare (86%)
- Manufacturing (86%)
- Pharmaceutical (71%)
- Biotechnology (57%)
- Professional Services (43%)
- Food and Beverage (29%)
- Information Technology (29%)
- Cosmetics (14%)
Please note that freelancers can work across multiple industries, so percentages overlap.
About the technology
MDSAP at a glance
MDSAP, the Medical Device Single Audit Program, lets one coordinated audit assess a medical device manufacturer against the requirements of participating regulatory authorities. It is built around ISO 13485 and adds regulator-specific expectations for areas such as production controls, post-market activities and reporting. Companies use it to support market access across participating jurisdictions while maintaining one connected quality system.
What MDSAP supports
MDSAP work covers the full medical device quality lifecycle, from planning and supplier controls to manufacturing, release and complaint handling. Typical assignments include:
- Preparing an organization for an MDSAP audit
- Mapping procedures to audit tasks and applicable regulations
- Managing nonconformities, CAPA and audit evidence
- Strengthening complaint, vigilance and post-market processes
Standards and tools
Strong MDSAP specialists work confidently with ISO 13485, risk management under ISO 14971 and relevant device regulations. They may also handle regulatory records, electronic quality management systems, supplier documentation, validation evidence and controlled procedures. In Germany, projects often connect MDSAP preparation with European quality and conformity processes without treating one framework as a substitute for the other.
When companies need specialists
Freelance expertise is useful when an internal quality team faces an upcoming audit, a new product scope or a major process change. It can also help after an audit reveals recurring findings or when a manufacturer needs an independent review before inviting an auditing organization. Clear signs include inconsistent records, unclear process ownership and CAPA that does not address root causes.
- Audit preparation lacks an accountable owner
- Procedures do not match actual operations
- Supplier and production evidence is incomplete
- Regulatory responsibilities are spread across teams
What strong professionals deliver
Effective MDSAP professionals translate audit tasks into practical actions for quality, regulatory, production and management teams. They understand how evidence is sampled, how processes connect and how a finding can affect several parts of the quality system. Their deliverables may include gap assessments, audit plans, evidence registers, revised procedures, training materials and CAPA follow-up.
Working with MDSAP expertise
A project works best when the specialist receives access to the quality system, audit history, product scope and process owners early. Remote collaboration is suitable for document reviews, interviews and preparation workshops; on-site work can add value during production walkthroughs, process observations and team training. Companies should assess whether the professional has handled comparable device classes, audit findings and regulatory markets rather than relying on generic quality experience.
Frequently asked questions
Need clarity? These are the questions we hear most often about MDSAP.
MDSAP is used to assess a medical device manufacturer’s quality management system through one coordinated audit for participating regulatory authorities. It helps companies align production, risk management, complaint handling and regulatory processes with shared audit expectations.
MDSAP uses ISO 13485 as a foundation but follows a more detailed audit model with regulator-specific requirements and a process-based scoring approach. ISO 13485 certification may be required or useful on its own, while MDSAP is relevant when a manufacturer seeks recognition in participating markets.
A strong MDSAP specialist usually understands ISO 14971, CAPA, supplier qualification, process validation, complaint investigations and post-market surveillance. Experience with electronic quality management systems and regulatory submissions is also valuable.
The right MDSAP professional depends on the assignment. A documentation gap review may need focused quality-system expertise, while audit readiness for a complex manufacturer calls for someone who has led cross-functional preparation, handled findings and worked directly with auditing organizations.
MDSAP preparation can often be performed remotely from Germany through document reviews, interviews, workshops and evidence tracking. On-site collaboration is useful for observing production, checking records at the point of use and training teams in their working environment.
Ask an MDSAP specialist to explain how they would map processes to audit tasks, test objective evidence and prioritize findings. Strong professionals connect recommendations to actual operations and can show how their work improved readiness without creating unnecessary documentation.
German medical device manufacturers with international market plans, changing product lines or complex supplier networks often benefit from MDSAP expertise. Specialists can coordinate quality, regulatory and production teams while keeping the work aligned with existing European compliance processes.
Before beginning, an MDSAP freelancer should review the device scope, quality manual, process map, audit history, open CAPA, complaint data and regulatory markets involved. Access to process owners and reliable records is essential for a gap assessment that reflects real operations rather than paperwork alone.
The average hourly rate of freelancers in Germany who have used MDSAP in their recent projects is 125 €, which corresponds to a daily rate of about 1,002 € 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 27 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 (86%), 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 Supply Chain Management (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
