Medical Device Vigilance


In 2015 the new regulation on Medical Devices will be published, strengthening the current legal framework and harmonizing practices among the EU Member States.

 

As a consequence, all medical device manufacturers as well as e.g. developer of mobile medical applications for smartphones have to have a Medical Device Vigilance System on place. The system is controlled by the respective national authorities and reminds of the vigilance system for pharmaceutical products.

 

Lindeq can support in various ways to be up to date and to meet the upcoming demands:

  • Training to get a solid understanding of requirements and, if wished, hands on exercises

  • If a Medical Device System is already in place, Lindeq can examine, update and maintain the system

  • If no system is in place, Lindeq can establish the system and update when needed

  • If only selected tasks are needed Lindeq can also support here, integrating these tasks seamless into the overall system

 

Lindeq supports with the following services:

  • Medical Device Vigilance system creation and maintenance (e.g. setting up Standard Operating Procedures (SOPs) and Work Instructions (WIs))

  • Incident handling, including clinical assessment and reporting to authorities

  • Audit or to help to become audit ready

  • Company Core Data sheet - CCDS

  • Field Safety Corrective Action

  • Field Safety Notice

  • Periodic summary / Trend reports

  • Hosting your Medical Device Vigilance System in a web-based Quality Management System  

  • Medical Device Vigilance training in new legislations for employees

  • Assistance in writing partner contracts from MEDDEV regulations perspective

 

For more detailed information go to Focus: Medical Device Vigilance or contact us directly.

 

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Lindeq has extensive experience in safety surveillance for different type of medical devices.

 

We have a diverse pool of employees such as doctors, engineers, and scientists with experience in different classes of medical devices. This diverse background enables us to provide tailor made services for a range of products such as drug delivery systems and in vitro diagnostics.

 

We assist manufacturers and importers in various ways to ensure they are up-to- date and that they meet the regulatory demands:

 

  • For a newly established company without a vigilance system in place Lindeq can establish and maintain the vigilance system, and act as a division of the company's supporting safety surveillance. 

  • We provide training to give clients a solid understanding of regulatory requirements concerning their products

  • If a Medical Device System is already in place, Lindeq can examine and help maintain the system

  • Lindeq can also support / perform individual tasks as per your vigilance system requirements

 

Regulatory requirements for medical device manufacturers and distributors have seen significant number of changes in the last few years:

 

In 2013, Medical Devices legislations have significantly been updated with stringent surveillance requirement to the Medical Device Manufacturers. Subsequently, EU has taken various measures to make sure these legislations are implemented strictly.

 

Furthermore, the implementation of the Regulation from 2014 set forth various criteria and requirements on functioning of the regulatory bodies but also helped with interpretations on the regulations. EU also initiated an action plan to further streamline and to better enforce the current legal framework by the EU Member States.

 

A consequence of the new stringent surveillance requirement on the medical devices manufacturers and distributors can impose significant demand on both the manpower and the skills, and experience of the employees for manufacturers, particularly for the small and medium sized companies.

 

 

                                                                                                                         

 

 








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