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Scientist’s Sanctuary aims to combine scientific knowledge with creative communication strategies to provide innovative, fun and easy to understand content in the life sciences and health care industries. Our aim is to understand your science and work closely with your team to ensure effective translation and communication.

What services do we offer?

Quality Management

We’ll work together with your team and build a Quality Management System that is tailored to your company.

Maintain Compliance

We’ll perform targeted audits to help you determine the status and health of your Quality Management System.

Independence

We provide many ready-to-edit templates that help you independently get started on implementation.

Industries of application

Medical Devices

Food & Beverage

Mining

Resources

10 Important Tips When Writing a Clinical Evaluation Report (CER) for Medical Devices

A clinical evaluation report (CER) is a vital document that combines both pre-market and post-market clinical data of a medical device. The CER should provide essential information on the safety, performance, and clinical benefit and is a requirement for medical device manufacturers to show they meet regulatory compliance and that their devices are safe and…

How To Classify Your Medical Device Under the EU MDR 2017/745

Did you know that under the EU MDR 2017/745, you now have to reclassify your medical device… even though it was previously classified under the old Medical Device Directive (MDD 93/42/EEC)? If you want to learn about classifying your medical device, then you’ve come to the right place! In this post we’ll be looking at…

How to Comply with the General Safety and Performance Requirements (GSPR)

In today’s post we’re talking about the General Safety and Performance Requirements (GSPR) under the new European Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). If you are a manufacturer trying to transition to the new MDR 2017/745 or IVDR 2017/746 or even just trying to get a CE mark for…