In Vitro Diagnostics and Medical Devices

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CE Marking – Quality Systems – Risk Management
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E-Labeling / eIFU

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Qarad is part of the QbD Group

We are proud to be a member of the QbD Group which supports life science companies worldwide throughout the entire product lifecycle – from idea to patient.

Together, we form a multinational organization with over 450 high-qualified employees offering services in regulatory affairs, clinical, qualification & validation, quality assurance, quality control, software solutions and go to marketRead more

 

News and Events

The Qarad touch: How a commitment to customer support spells success for IVD and medical device customers

The information in instructions for use (IFU) for medical devices and in vitro diagnostics (IVD) is both highly regulated and fundamental to patient safety. For manufacturers of medical devices and IVDs, it is essential to know they can rely on their service providers. Thanks to Qarad’s deep expertise in IVDs and medical devices and its long experience in regulatory affairs, its service stands out from the rest.

New and updated MDCG Guidance documents released!

On March 24th, 2022, the Medical Device Coordination Group (MDCG) released a revision to an existing guidance. In addition, on April 26th and May 4th the MDCG released two new documents. The previously released guidance on the summary of safety and clinical performance, a guide for manufacturers and notified bodies (MDCG 2019-9) was updated to revision 1. While the two new documents provide guidance on the borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices (MDCG 2022-5) and offer guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR (MDCG 2022-6).

RAPS 2022 Euro Convergence - May 10-12 2022
RAPS

Qarad will be present at the RAPS 2022 Euro Convergence from May 10 to 12 in Amsterdam, the Netherlands. Our Vice-President, Dr. Maurizio Suppo, will speak about regulation changes (EU IVDR) and high risk IVDs on May 11.

Qarad integrates EU’s Implementing Regulation 2021/2226 on eIFU for medical devices

The European Commission has made changes to rules governing the provision of electronic instructions for use (eIFUs) for medical devices (MDs), as originally laid down in Regulation 207/2012. Qarad immediately applied the new EU provisions to their services and informed every customer of this change.

New and updated MDCG Guidance documents released!

An updated version was released of the guidance on performance evaluation of SARS-CoV-2 IVDs. Moreover, two new documents were published to provide information regarding the verification of manufactured class D IVDs by notified bodies and to offer guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD.

New MDCG Guidance documents released!

MDCG published a notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices (MDCG 2022-1) and offers guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (MDCG 2022-2).

IVDR Amending Regulation Published!

The IVDR amending regulation 2022/112 as regards transitional provisions for certain in vitro diagnostic medical devices was published!

The added value of Qarad’s multilingual freephone service to their eIFU solution

Government regulations for MD and IVD products allow manufacturers to provide IFUs digitally in the form of portable electronic storage media (e.g. CD or USB) or via the company’s website. Although these digital IFUs are allowed, the manufacturers are still obliged to provide an alternative means so clients can obtain paper copies on request. Qarad’s free telephone service guarantees quick and efficient handling of these requests without any burden to the manufacturer.

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