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pfm medical msg - validating, sterilising, monitoring
pfm medical msg, established in 2005, operates one of Europes most modern ethylene oxide sterilisation plants in the German state of Saarland. We would love to work for your company, too.
Our standards:
-Development of specific sterilisation cycles for your products.
-Certified quality management system.
-Validation of sterilisation processes.
-Compliance with all environmental laws and regulations.
For each batch, you receive certification of physical parameters and microbiological in-process control. A team of highly qualified staff is on hand throughout the entire process, to advise you with regard to all questions pertaining to sterilisation, validation and legal regulations.
pfm medical expert
From A for analyses to Z for approval
pfm medical expert specializes in consulting on all regulatory requirements for medical devices in accordance with MDR (EU Medical Devices Regulation) and support in clinical project management and quality management. Our team consists of academics and highly qualified specialists with different areas of expertise. Together, we have over 150 years of experience, which we use to develop the appropriate clinical and regulatory strategy together with you.
Our portfolio includes, for example, statistical evaluations and analyses, clinical studies and assessments, database systems, programming and provision of electronic patient record forms (eCRF), and support for the CE marking of your medical devices.
Our offer is aimed at established medical device manufacturers and ambitious companies that want to enter the European market. We offer solutions that are optimally tailored to your company´s requirements and your products.
Please contact us.