Whitepapers

[Whitepaper] Verification & Traceability Guide for Wholesalers

A brief overview of the wholesalers` obligations regarding verification and traceability according to EU FMD requirements.     What is a designated wholesaler?   A designated wholesaler is a company (sales affiliate/licensee/co-marketer and holder of a wholesale distribution authorization), designated through a license/agreement with the Marketing Authorization Holder (MAH) to...

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EUDAMED Updated timeframe

[Whitepaper] EUDAMED Implementation – updated timeframe

  Discover the updated timeframe for implementation of European Database for exchange of medical devices information   Download the whitepaper and find out what is the new timeframe of EUDAMED Implementation, confirmed by European Commission   [formidable id=39]  ...

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[Whitepaper] UDI – from the Basics to the Benefits

  Get the most detailed information about UDI - everything that supply chain participants need to know!   With the implementation of theย Medical Devices Regulation (MDR), it became apparent that manufacturers should assignย UDI to medical devices. This is intended to allow the identification and to improve the traceability...

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[Whitepaper] Key steps towards safe and sustainable pharma packaging

The Pharma industry makes steps towards utilizing sustainable practices in packaging for years.   Due to the complex nature of the industry, the steps are small but definitive towards sustainable packaging. It`s important to mention that the environmental impact of pharma packaging is small compared with other...

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[Whitepaper] Top 10 security advantages of cloud services

Cloud services are gaining traction. Because of their nature, the pharma industry is still looking with disbelief at them. We want to prove to you that the cloud-based solution could be as secure as this on-premises. โ€œThere are two sides to the coinโ€, let`s get...

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[Whitepaper] Checklist – Top MDR questions

  The transitional period to MDR is complex and full of questions - get the answers now!   In 2017 the Medical Devices Regulation (MDR) was published and marked the start of a four-year journey of transition from MDD to AIMDD. From the 26th of May 2021, the...

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mdr questions

[Whitepaper] Frequently Asked Questions About Medical Devices

  The EU's Medical Device Regulation (MDR) was officially published on 5 May 2017 and came into force on 25 May 2017. The MDR will replace the EUโ€™s current Medical Device Directive (93/42/EEC) and the EUโ€™s Directive on active implantable medical devices (90/385/EEC).   In this whitepaper, you...

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