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Advice and best practices for writing SOPs, training for product launch, outsourcing technical documentation, and more.

Top 5 IVDR 2017/746 FAQs

Similar to the EU Medical Device Regulations (MDR), the new In-Vitro Device Regulations (IVDR 2017/746) are set forth to increase patient safety. To successfully transition to the new regulations, manufacturers need to prepare their products and ...
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New Clinical Evaluation Report Solution for EU MDR Compliance

As of May 2020, medical device manufacturers who sell devices in Europe must comply with more comprehensive regulations set forth by the European Medical Device Regulation (EU MDR). With numerous clients affected by this, Novatek has launched a Clinical ...
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10 Basic Technical Writing Practices for Subject Matter Experts

Standard Operating Procedures (SOPs) are written instructions that a worker follows to perform a given task consistently and effectively. These documents communicate who will perform the task, what materials are necessary, where and when when the task ...
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Improving Quality Control & Process Protection: Developing an Effective SOP Process

For companies in regulated industries, effective Standard Operating Procedures (SOPs) are important to the ability to manage quality control and process protection. Below we share best practices and tips for developing and managing an SOP process that ...
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ISO Certification Cost: Reducing Expenses in Quality System Management

Being ISO certified offers manufacturers many benefits and opens up new opportunities, but planning for the costs of operating under these standards is an important factor of the certification. From the documentation to the training and implementation ...
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