Free On-Demand Webinar for MedTech QA/RA Leaders

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... Read more

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 up team members according to their professional background. Simon convinced me with his knowledge regarding the following topics: -Process validation -Gage R&R -CAPA Management/Root cause analysis -Quality & Supplier Management -Statistical techniques I appreciate the collaboration with him very much and would call on him again for a project at any time.

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... Read more

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 understand the specific business and business needs, and then helped the team to translate the regulatory requirements into applicable tactics and to develop the most suitable process. His guidance was crucial to help the team to navigate the complexity and ambiguity behind such a complex topic and to develop a sustainable approach. His specific experience and ability to share industry practice and NB expectations allowed the team to focus on the key elements and to develop a process that meet all the business needs and requirements. Very appreciated.

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... Read more

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 friendly, patient, and solution-oriented medical consultant from whom we have learned a lot. Thank you very much for your support!

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... Read more

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 carry out extensive audits with a significantly increased level of detail, within our time constraints. The audit results (internal audits and supplier audits) were accepted by suppliers and by our specialist departments and provided important input.

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... Read more

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 justify the sample size reliably and in compliance with ISO 16269-6. Their proactive and cooperative approach truly impressed us – a collaboration we can wholeheartedly recommend.

SIFo Medical was like opening Pandora’s box for us – in the best way. We realized that while we had already been doing many things right, SIFo Medical helped us see where we could grow and further improve the processes we had established.

SIFo Medical was like opening Pandora’s box for us – in the best way. We realized that while we had already been doing many things right, SIFo Medical helped us see where we could grow and further improve the processes we had established.

We had a training on process validation and test method validation at our company. SIFo addressed the topics perfectly and used our own case examples to explain certain aspects in more detail.

We had a training on process validation and test method validation at our company. SIFo addressed the topics perfectly and used our own case examples to explain certain aspects in more detail.

Our notified body required proof of a test method validation for the tests assessing seal seam quality in accordance with ISO 11607-1. The TMV Guide from SIFo Medical was an outstanding support throughout this process. The video guides were especially valuable – clear, practical, and perfectly ... Read more

Our notified body required proof of a test method validation for the tests assessing seal seam quality in accordance with ISO 11607-1. The TMV Guide from SIFo Medical was an outstanding support throughout this process. The video guides were especially valuable – clear, practical, and perfectly aligned from start to finish. The templates integrated seamlessly into our QMS, and we were able to complete the entire validation in just a quarter of the usual time. Support from SIFo Medical was prompt, knowledgeable, and solution-oriented. Overall, it’s a comprehensive, well-structured package that we can highly recommend.

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... Read more

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 confident that he will return with exceptional results in a minimum of time. He developed whole concepts and strategies on his own, fitting into a complex medical environment. Several times I caught myself choosing Simon as the person to go for difficult topics that are urgent, complex, and important. Things where failure was unacceptable. Anytime I would need a team player for tough topics in a sensitive team with high-reliability, Simon would be my first call.

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... Read more

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 collaboration with Simon is very harmonious and constructive. I recommend Simon thoroughly and am convinced he is an excellent addition to the team.

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 ... Read more

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 immediately. SIFo initially pursued these proposals on several tracks to avoid losing time until we finally found the right product for us. Due to the smooth and uncomplicated process, this will certainly not be the last cooperation between our two companies!

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... Read more

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 up team members according to their professional background. Simon convinced me with his knowledge regarding the following topics: -Process validation -Gage R&R -CAPA Management/Root cause analysis -Quality & Supplier Management -Statistical techniques I appreciate the collaboration with him very much and would call on him again for a project at any time.

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... Read more

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 understand the specific business and business needs, and then helped the team to translate the regulatory requirements into applicable tactics and to develop the most suitable process. His guidance was crucial to help the team to navigate the complexity and ambiguity behind such a complex topic and to develop a sustainable approach. His specific experience and ability to share industry practice and NB expectations allowed the team to focus on the key elements and to develop a process that meet all the business needs and requirements. Very appreciated.

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... Read more

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 friendly, patient, and solution-oriented medical consultant from whom we have learned a lot. Thank you very much for your support!

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... Read more

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 carry out extensive audits with a significantly increased level of detail, within our time constraints. The audit results (internal audits and supplier audits) were accepted by suppliers and by our specialist departments and provided important input.

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... Read more

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 justify the sample size reliably and in compliance with ISO 16269-6. Their proactive and cooperative approach truly impressed us – a collaboration we can wholeheartedly recommend.

SIFo Medical was like opening Pandora’s box for us – in the best way. We realized that while we had already been doing many things right, SIFo Medical helped us see where we could grow and further improve the processes we had established.

SIFo Medical was like opening Pandora’s box for us – in the best way. We realized that while we had already been doing many things right, SIFo Medical helped us see where we could grow and further improve the processes we had established.

We had a training on process validation and test method validation at our company. SIFo addressed the topics perfectly and used our own case examples to explain certain aspects in more detail.

We had a training on process validation and test method validation at our company. SIFo addressed the topics perfectly and used our own case examples to explain certain aspects in more detail.

Our notified body required proof of a test method validation for the tests assessing seal seam quality in accordance with ISO 11607-1. The TMV Guide from SIFo Medical was an outstanding support throughout this process. The video guides were especially valuable – clear, practical, and perfectly ... Read more

Our notified body required proof of a test method validation for the tests assessing seal seam quality in accordance with ISO 11607-1. The TMV Guide from SIFo Medical was an outstanding support throughout this process. The video guides were especially valuable – clear, practical, and perfectly aligned from start to finish. The templates integrated seamlessly into our QMS, and we were able to complete the entire validation in just a quarter of the usual time. Support from SIFo Medical was prompt, knowledgeable, and solution-oriented. Overall, it’s a comprehensive, well-structured package that we can highly recommend.

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... Read more

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 confident that he will return with exceptional results in a minimum of time. He developed whole concepts and strategies on his own, fitting into a complex medical environment. Several times I caught myself choosing Simon as the person to go for difficult topics that are urgent, complex, and important. Things where failure was unacceptable. Anytime I would need a team player for tough topics in a sensitive team with high-reliability, Simon would be my first call.

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... Read more

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 collaboration with Simon is very harmonious and constructive. I recommend Simon thoroughly and am convinced he is an excellent addition to the team.

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 ... Read more

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 immediately. SIFo initially pursued these proposals on several tracks to avoid losing time until we finally found the right product for us. Due to the smooth and uncomplicated process, this will certainly not be the last cooperation between our two companies!