MDSAP Experts in Germany
in minutes from over 15,000 CVs with the power of AIWork with specialists who align ISO 13485 quality systems with global market authorities, conduct mock audits, and remediate non-conformities, quickly matched through vetted freelancer profiles.
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
26 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 19 Sep 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 19 Sep 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
Harmonized Global Quality Audits
The Medical Device Single Audit Program allows medical device manufacturers to satisfy the regulatory quality management standards of five global authorities through a single comprehensive audit. Built upon ISO 13485, it covers requirements from the US FDA, Health Canada, Australia TGA, Brazil ANVISA, and Japan MHLW/PMDA.
Core Competencies in MDSAP Execution
- Process-oriented audit model structuring and gap analysis
- Medical device reporting and vigilance alignment across jurisdictions
- Technical documentation and design history file compliance
- Supplier evaluation and purchasing control harmonization
- Management review and CAPA workflow remediation
Regulatory Landscape in Germany
German medical device manufacturers frequently export abroad while maintaining compliance with EU MDR. Specialists in Germany bridge the structural differences between European notified body expectations and the strict process-based audit methodology mandated by participating MDSAP jurisdictions, ensuring documentation satisfies both domestic and overseas market entries.
Auditing Organizations and Tooling
Navigating an audit requires deep familiarity with Auditing Organizations like TUV SUD, DEKRA, and BSI. Professionals leverage electronic quality management systems such as MasterControl, Veeva Vault, and Qualio, alongside MDSAP Companion Document matrices to trace every requirement to internal standard operating procedures.
When External Expertise Is Required
- Transitioning from standard ISO 13485 certification to multi-country market authorization
- Facing recurring non-conformities or audit findings under the grading matrix
- Shortage of internal audit staff during mandatory re-certification cycles
- Expanding device distribution into the Canadian or Brazilian markets rapidly
Attributes of Outstanding Specialists
Top specialists demonstrate a deep understanding of the grading system for non-conformities and can predict how auditors evaluate process linkages. They communicate fluently in both English and German to interface seamlessly between local quality teams and international regulatory bodies.
Frequently asked questions
Need clarity? These are the questions we hear most often about MDSAP.
The Medical Device Single Audit Program allows a single regulatory audit of a medical device manufacturer's quality management system to satisfy the requirements of multiple international jurisdictions. It consolidates oversight across the United States, Canada, Brazil, Japan, and Australia into one coherent review structure.
While ISO 13485 forms the baseline, MDSAP integrates specific country-specific regulations into each audit task. It also enforces a strict, sequence-based audit approach and a standardized non-conformity grading system that ordinary ISO 13485 audits do not utilize.
Holding MDSAP certification is mandatory for medical device companies in Germany that sell into the Canadian market. It also substantially reduces the frequency of routine inspections by the US FDA and accelerates product licensing through ANVISA in Brazil.
A competent professional should have strong command of MDSAP, alongside deep knowledge of EU MDR, post-market surveillance systems, risk management under ISO 14971, and validation protocols for electronic quality management systems.
Much of the documentation review, procedure writing, and gap analysis for an MDSAP project can be performed remotely. However, mock audits and final preparation runs often benefit from on-site walk-throughs at German manufacturing facilities to observe live shop-floor practices.
The Companion Document acts as the definitive instructional guide used by auditors during an MDSAP assessment. Experienced specialists use it to map internal procedures step by step against regulatory expectations across all five participant countries.
Verify whether the professional has steered previous manufacturers through successful initial audits or recertifications without critical non-conformities under MDSAP. Experience defending CAPA systems directly in front of accredited Auditing Organizations is a strong quality marker.
Audits are predominantly documented and conducted in English, but native or fluent German is invaluable when reviewing local quality records. It also allows an MDSAP professional to collaborate smoothly with internal production personnel on German shop floors.
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 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 (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
