Quality Management

At SIFo Medical, we help you close compliance gaps and make your quality management system audit-ready – with expert support in design control, packaging validation, process validation, test method validation, and risk management.

Avoid Costly Mistakes & Identify Quality Gaps.

Often, while working with our clients, we uncover hidden quality gaps they weren't aware of. We proactively identify these issues and collaborate with you to develop efficient, tailored solutions that strengthen your quality management system.

Tailored Solutions, Built for Your Needs.

Your quality challenges are unique, and so are our solutions. With direct communication and customized strategies, we work with you to improve your processes, and create an efficient and compliant quality management system.

Count on MedTech Know-How & Hands-On Support.

With extensive knowledge and experience in quality management and regulatory requirements, we ensure your QMS is efficient, compliant, and built for long-term success.

Forward-Thinking Compliance – Staying Ahead in a Changing Industry.

Regulations evolve, and so do we. At SIFo Medical, we stay ahead of industry changes, ensuring your quality management system is not only compliant today but prepared for tomorrow.

Our Services

Design Control Process Validation Packaging Validation Test Method Validation Risk Management

Our Services

Design Control

From concept to compliance – ensure your medical device meets regulatory expectations from day one. We support you in navigating design control requirements, streamlining documentation, and establishing a solid foundation for your successful product development.

Case study

Design Control for Medical Devices

Process Validation

Get in power over your processes – ensure your process consistently produces output, that meets its specifications. We support you in all phases of medical device process validation (IQ, OQ, PQ).

Case study

Medical Device Process Validation

Packaging Validation

Ensure your packaging maintains sterile and protects your medical device throughout its lifecycle. More than a checkbox for compliance, it's a safeguard for patient safety and brand reputation – proving your packaging performs under real-world conditions.

Case study

Packaging Validation

Test Method Validation

Test method validation (TMV) is a regulatory must-have in MedTech. It’s key to reliable testing results and consistent product quality. When done right, TMV reduces complaints, builds trust in your processes, and ensures compliance and product quality.

Case study

Test Method Validation

Risk Management

Effective risk management is the backbone of safe and compliant medical devices. At SIFo Medical, we help you implement ISO 14971-compliant risk management systems that go beyond documentation – integrating risk thinking into your design, manufacturing, and post-market processes.

Case study

Medical Device Risk Management

Success Stories

At SIFo, you have a direct contact person with interdisciplinary competencies who combines technical, qualitative, and business know-how. We have significantly benefited from the direct communication channels SIFo maintains with its suppliers. We received several proposals for possible solutions ...

Louis Andres

Head of Purchasing

I was working with Simon for one year on a PCBA testing concept. His role was to qualify and validate a Flying Probe machine and other testing machines. His way of tackling and solve problems was a key attribute to the success of the project. Every time I passed on an activity, I was very confide...

Sergej Sobolewski

Project Manager

We carry out audits worldwide with Resyca, some of them with very specific industry sectors. We are therefore also dependent on external auditors. We came to SIFo Medical via a recommendation. The communication went smoothly right from the start. With the support of Mr. Foeger, we were able to ca...

Dr. Raimund Gleixner

Head of Quality & Regulatory Affairs

I worked with Simon for about 3 years in an interdisciplinary team on an international project. With Simon's support, we successfully overcame both intercultural and time-critical challenges. Simon is an all-rounder. He quickly familiarizes himself with complex topics and knows how to pick u...

Anna Spehl

Head of Production Engineering

With Simon, we have a top consultant at our side at Dr.Ausbüttel. Together, we have developed and performed test method validations that provide a firm basis for our quality work in MDD and MDR audits. SIFo Medical's great strength is its network. No question goes unanswered. Simon is a fri...

Axel Brauckmann

Head of Quality Assurance

Simon was very instrumental in supporting our cross-function team during the assessment and the definition of an appropriate and compliant approach to process validation. With an hands-on approach and thanks to his concrete expertise and experience he first quickly got the actual picture to under...

Riccardo Pellegrini

Global Head QM/RA

The collaboration with SIFo Medical was excellent in every respect. We particularly appreciated the transparent and timely communication as well as the clear and comprehensible explanations. Thanks to their support, we were able to establish a connection between risk management and validation and...

Pierre Koenen

Quality Manager

Simon is an honest, motivated, and efficient personality. We had the opportunity to work together over short phases, where Simon was very self-sufficient and approached issues proactively. With his expertise, he was able to handle tasks very quickly on his own. Due to his open nature, the collabo...