The course Sterilization of Medical Devices has existed for over 30 years and hundreds of people have graduated from it.
Now, Key2Compliance has acquired the course, which is the only one of its kind in the EU.
”We are extremely happy to be able to offer this unique and very successful course”, said Åse Ek at Key2Compliance.
For anyone who is going to work with auditing sterilization processes within the segment of medical devices, it is seen as almost mandatory to complete the Sterilization of Medical Devices course. It was developed as part of a university course at the University of Manchester in the early nineties, but was later converted into an open, stand-alone course. Since 2010, it has been hosted by consulting company Preventia – but now Key2Compliance has acquired the course.
“I was pleasantly surprised when Anette Sjögren from Preventia contacted me and asked if we wanted to take over responsibility for the course. It’s an honor that she turned to us. Sterilization of Medical Devices is used by both industry, authorities and notified bodies to train their own inspectors and auditors, and we are extremely happy to be able to offer this unique course” said Åse Ek, Senior Consultant and Trainer at Key2Compliance.
The course is the only one of its kind in the EU, which gives Key2Compliance an even stronger position on the market for training in the medical device segment. Since Preventia began offering the course around thirteen years ago, hundreds of students have graduated.
“I felt it was time for someone else to operate this important course and that’s why I turned to Key2Compliance. It feels very good that they will host Sterilization of Medical Devices. They have a solid reputation in the industry and this course is a great addition to their existing offering in education and training” said Anette Sjögren, CEO and owner of Preventia.
Anette Sjögren supports the handover and will, during a transition period, act as a teacher on certain parts of the course. Several people have already signed up for the course this fall, which starts on November 20, with participants from industry, authorities and certification bodies from the USA, EU, and Asia, among others. The course lasts five days and takes place in Copenhagen.
In addition to the course Sterilization of Medical Devices, Key2Compliance has a wide range of training within medical device, IVD, pharmaceuticals and combination products. In total, around 60 courses are offered, in the fall 2023 alone.
Key2Compliance offers complete and optimized solutions within Regulatory compliance. Key2Compliance are a full-service partner that offers consulting and training for medical devices, In Vitro Diagnostics, and pharmaceutical companies. Key2Compliance area of expertise are medical device QA, pharma QA, clinical development (CRO), biological safety, regulatory affairs and training and courses. Key2Compliance job is to make the complex easier and to help companies interpret and implement the rules effectively to comply with the regulations, while developing a long-term sustainable business. Key2Compliance will help you reach an optimal level of regulatory compliance without investing too much time and resources.
For more information, please contact:
Senior Consultant & Trainer
+46 (0)70 561 0186