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Finding solutions to meet Clinical Evaluation needs

As of right now, the changes brought on by MDR have quickly heightened the need for clinical evaluation in the medical technology field. During the directive, the approach to clinical evaluation was...

Pitfalls of postponing quality control in SaMD manufacturing – Quality expert Linda Kellberg interviewed

Do you think of quality management as only one part of the progress of bringing your software device to the market? Preferably one that can be checked out as a last step before your software device...

Problems and solutions in MDR transition – Innokas Medical at Health Valley Event

Innokas Medical is present at the Health Valley Event (HVE) that will take place on March 30 with the theme of affordable and accessible healthcare supported by technological innovations. Make sure...

Specialist’s insight – How to tackle the changes within the transition periods of regulations?

Manufacturers who have devices CE Marked to the directives MDD, AIMDD or IVDD (i.e., legacy devices) have deadlines for regulatory compliance if they want to keep their devices on the European...

The expansion of clinical evaluation has increased the need for clinical competence in companies designing medical devices

The new MDR regulation has expanded the need for clinical evaluation in companies designing medical devices. The interview for my master's thesis highlighted the requirements set by the new...

Innokas Medical addresses the growing need for clinical affairs services

Innokas Medical strengthens its QA&RA services with a new Clinical Affairs team. The new team supports medical device companies in carrying out resource-binding clinical evaluation related work by...

Specialist’s insight – What is the current availability of Notified Bodies?

Ever since the European Commission published the new regulations for medical and in-vitro diagnostic devices, there have been serious concerns regarding the availability of medical devices and how...

Specialist’s insight – Is there a way for rapid market entry for medical devices?

Innokas Medical launched a service called MDR Fast Track earlier this year. The service enables MedTech companies to enter markets faster with reasonable effort and acceptable risk by outsourcing the...

HIMSS 2022 Europe – Three Days of Health, Care & Wellbeing

The hot topics in HIMSS (Healthcare Information and Management Systems Society) Europe exhibition in Helsinki were human centricity and how to enable easier connectivity and interoperability with...

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