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

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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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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Ensuring Your Standard Operating Procedures are Effective & Usable

Maintaining consistency in business process is essential to successful operations in any organization. For many manufacturers, the development and implementation of Standard Operating Procedures (SOPs) is one way to ensure quality and reduce risks.
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Artificial Intelligence & Customer Service: Technical Documentation & Documented Processes are Key

As technology continues to change the methods of daily interactions, manufacturers are starting to see these changes impact the customer service dynamic. Customers are using chatbots every day, from Siri to Alexa, and advances in artificial intelligence ...
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Avoiding Customer Loss: Standardize SOPs After A Merger or Acquisition

In recent years, the medical device industry has experienced a trend of consolidation through mergers and acquisitions (M&A). Due to continued globalization and high demand for medical products and services, as well as pricing pressure, medical device ...
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 EU MDR