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Medical Device Expertise

Product Documents and Training Development Solutions 

Medical   |   Manufacturing   |   Cyber Security

Medical Devices Save Lives – When Used Properly

Continued competition, global markets, recall concerns, and stringent FDA regulations have made product documentation more critical than just fulfilling a labeling requirement. A user-focused documentation process is the most efficient way to control costs without delaying product launches or risking recalls. We will plan, design, develop, produce, and maintain your medical device product documents so you can focus on creating a great product.

 

Helping you meet EU MDR MEDDEV 2.7.1 Revision 4

Medical device manufacturers have until May 2020 to meet new compliance standards. With our EU MDR compliance solution, you'll transition with ease.

  • Clinical Evaluation Reports
  • Post-market surveillance plan and reports
  • Standard Operating Procedures
  • Instructions for Use (IFUs)
  • QMS documentation

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Core expertise

Medical devices are only as effective as their sales, service, and users. Make yours as powerful as possible by ensuring its safe and accurate use. While gathering the knowledge and developing accurate and usable reference materials is time-consuming and complex, falling behind is not an option. That’s where Novatek comes in.

Novatek provides product documentation and training that is error-free and on time, including:

  • Instructions for Use (IFUs) / Directions for Use (DFUs)
  • Clinical Evaluation Reports
  • Labeling
  • User Manuals
  • Service Manuals
  • Installation Instructions
  • Online or instructor-led training
 

We can also keep your organization’s quality systems process documentation up to date and compliant using:

  • Workflows
  • Standard operating procedures (SOPs)
  • Work instructions

 

 

 

Are you audit-ready?

A properly documented quality system can help speed compliance and reduce risk. Download our free checklist to see if your process is audit ready

Get Checklist

 EU MDR

A med device company’s new product required training a new audience, but limited documentation and a lean staff made development a challenge.
This on-time, on-the-mark eLearning was ready for worldwide launch, helping them differentiate in a crowded market.

Case Studies

 

You’ll be LaunchReadywe guarantee it. 

How can we help?

Leverage our technical writing team for your next project.
 
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