Regulatory

Clinical Evaluation Report (CER)

Although the new Medical Device Regulation in the EU is almost officially approved, MEDDEV 2.7/1 has already been updated according to the expected requirements. Per 29 June 2016, the updated MEDDEV has been put into practice without transition period, and Notified Bodies therefore already implement this in their approval process. That means that all devices (from class I to III), whether they are new or already on the market for a long time, are required to have up-to-date CERs. Note here that MEDDEV 2.7/1 rev. 4 requires evaluators to have knowledge of research methodology, information management, regulatory requirements, medical writing ánd minimum 5-10 years experience in the relevant field. 
Factory has an expert team of medical writers that has this knowledge and experience and that can help you compiling these reports making sure you do it right the first time so you don’t loose time and resources. We can help you designing a protocol for reviewing existing literature data, new clinical data, and all your internal reports (including your post marketing surveillance data) to relate to your risk analysis. Clinical Evidence

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FDA submissions

Procedures for FDA submission and approval are complex, requiring different strategies for each type of medical device or IVD. Adequate knowledge of the requirements of each access route is therefore essential. We have an extensive knowledge pool available, helping you through each step of the submission process.

Postmarketing Surveillance (PMS)

The transition from clinical development to marketplace introduction is critical to the success of a product. Post-marketing surveillance studies can give you the valuable information you need to optimize your product’s potential and gain competitive advantage.
Factory has expertise in the design, conduct, analysis and reporting of PMS studies. Results from well-designed PMS studies can strengthen your marketing and sales efforts. Factory is eager to work with you to achieve the scientific credibility of PMS studies and to maximize your product’s exposure.

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CE marking

We are well acquainted with CE-marking studies and can assure that your study can be designed and controlled to meet the demands of Notified Bodies. Our strategic establishment in Europe with ISO9001-2008 certified Standard Operating Procedures that comply with the ISO14155 standard will provide you great advantage.