OUR GOAL IS TO HELP YOU ACHIEVE THAT BY FACILITATE COMPLIANCE WITH APPLICABLE REGULATORY FRAMEWORK.
The idea behind Kickfile originated back in 2016 when Devicia AB, a medical device exclusive CRO, observed a need amongst their clients. Working with clinical investigations requires a thorough knowledge of applicable laws, regulations and guidelines. Thus, when undertaking a clinical investigation it is not sufficient to only be aware of applicable laws and regulations, you also need to know how the current legislation should be applied in order to gain control of the activities. With that in mind Kickfile was established, with the aim to increase awareness, strengthen the compliance and facilitate clinical activities.
Systems to support MDR compliance
Licensing or purchasing our systems gives immediate access to QMS documents for medical device manufacturers. Our systems are developed based on the requirements in MDR, ISO 14155:2011, MEDDEV 2.7/1 rev.4 and MEDDEV 2.12./2 rev.2. Additionally, the systems have been audited by EU & US external auditors, and been used operationally in the EU and US. Our systems are continuously updated to cover e.g. publications of new standards, Common Specifications and MDCG documents.
Quick access to the files you need
Setting up quality management systems takes a significant amount of time and resources for a device manufacturer. With Kickfile, you get access to SOPs, templates and forms for the processes you need whether you are planning a clinical investigation, is in the process of updating a clinical evaluation, or needs to perform PMCF activities. Kickfile simplify clinical activities and facilitate compliance with applicable regulatory framework (e.g. ISO 14155 and MDR).
Do what you do best – we’ll cover the rest
By using Kickfile, you can quickly have the right, compliant systems in pace and focus on the activities that you do best. In addition to the QMS you license or purchase – we provide you with support to implementing and using the systems to the extent you require. With reliable systems in place, it’s easier to utilize internal resources and avoid a multitude of systems based on e.g. what your CRO or consultancy organization uses.