Medical Device Vigilance

 

Lindeq supports with individual tailored medical device safety services. By this you have a medical device vigilance system in place, comprising reviewing and updating any safety issues as well as the submission of vigilance reports to the respective Competent Authority.

 

  • Lindeq examines your already established procedures and advise on aspects like efficiency and compliance.

  • Lindeq can set up and implement a Medical Device Vigilance system, tailored to the client's individual needs, prepared either with Lindeq templates or the client's template.

 

After implementation we can perform regular maintenance of the system, including maintenance of written procedures, documentation and follow-up of reported events, and if required, communication with the Competent Authorities.

 

For more detailed information please contact us directly. Together we will find the best solutions to fit your individual needs. 

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Operational pharmacovigilance
ICSR management, EudraVigilance, RMP, CCSI, PSUR, DSUR, Signal management, XEVMPD, and many more.
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Pharmacovigilance System
QPPV/deputy QPPV, SOPs, Quality Management Systems, (electronic) PSMF
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Clinical safety & PASS
Management of SUSARs and SARs, safety narrative writing, medical assessments and DSUR
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Medical Device Vigilance
Full range of medical device safety services for all different types of medical equipment
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Quality Management System
Web-based quality management system software including training and document management
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PV, RA and Medical Support
Includes among others: ad hoc assistance, audits, training, assessment of risk-benefit, medical and scientific writing services
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Pharmacovigilance related IT
PQ validations, data migrating and mapping, safety database software, EMA gateway testing
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Cosmetovigilance
Full range of cosmetic product safety services for all different types of cosmetic products

NEWSLETTER SIGNUP

- quarterly issued

- topics within pre- and post marketing PV

                       medical device vigilance

                       quality management

- prepared by our respective specialists