Medical Device Software

Through Kickfile you can gain access to systems that have been optimized to fulfill the requirements for Medical Device Software.

Whether a software qualifies as a medical device or not depends on its intended purpose.

Through Kickfile you can gain access to systems that have been optimized to fulfill the requirements for Medical Device Software.

Software is a medical device if the intended use falls into the scope of the current regulations of medical devices. However,the new Medical Devices Regulation (MDR 2017/745) and In Vitro Diagnostics Regulation (IVDR 2017/746) brings changes in concepts, definitions and procedural requirements which affect all stakeholders in the MedTech industry, particularly the manufacturersofmedical device software.

Many class I standalone software products will be pushed into a higher classification by the MDR. This higher classification brings several additional responsibilities, including engagement with a notified body.

Kickfile have established systems that can be used to facilitate compliance for your medical device software.

These are the service needed for medical device software:

Clinical Evaluation

The increased requirement of the clinical evaluation process became clear already in 2016 when the 4th revision of the MEDDEV 2.7/1 was published. Since then the importance of the clinical evaluation has been increasingly stressed in the EU Medical Device Regulation (MDR 2017/745). Let Kickfile’s system guide you through the requirements and provide you with a document structure that has gone through a multitude of Notified Body reviews.

The increased requirement of the clinical evaluation process became clear already in 2016 when the 4th revision of the MEDDEV 2.7/1 was published. Since then the importance of the clinical evaluation has been increasingly stressed in the EU Medical Device Regulation (MDR 2017/745). Let Kickfile’s system guide you through the requirements and provide you with a document structure that has gone through a multitude of Notified Body reviews .

Clinical evaluation is an ongoing process  to collect, appraise and analyze clinical data throughout the life cycle of a medical device. In general, it is first performed during product development to identify data that need to be generated for market access. Clinical evaluation is mandatory for initial CE - marking and must be actively updated thereafter.

Clinical evaluation is necessary and important because it ensures that the evaluation of safety and performance of the device is based on sufficient clinical evidence throughout the lifetime that the medical device is on the market.

Whether you are developing a new  medical  device or need to update your clinical evaluation Kickfile’s system provides you with the tools that you need to ensure compliance with MEDDEV 2.7/1 rev. 4 and MDR.

Performance Evaluation

The requirement for a pre-market performance evaluation is already implied by the current in vitro diagnostics directive (IVDD). However, the new EU In Vitro Diagnostics Regulation (IVDR 2017/746) includes explicitly stated requirements clarifying that manufacturers of all IVDs, regardless of classification, shall plan, conduct and document a performance evaluation in accordance with the IVDR. Let Kickfile’s system guide you through the requirements and provide you with a compliant document structure.

Performance evaluation means an assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device. According to the IVDR, clinical evidence must support the intended purpose of the device as stated by the manufacturer and be based on a continuous process of performance evaluation, following a performance evaluation plan.

Whether you are developing a new IVD medical device or need to update your performance evaluation Kickfile’s system provides you with the tools that you need to ensure compliance with IVDR.

Clinical Investigation

A clinical investigation is a complex process with a comprehensive regulatory framework. Our system guides you through all the steps needed for your clinical investigation, regardless if it is a pre-or post-market study, and makes your journey from study idea to fully executed investigation swift, transparent and agile.

Regardless of the reasons for initiating a clinical investigation, it comprise of a widespread process and comprehensive regulatory framework. Clinical investigations must take into account scientific principles underlying the collection of clinical data along with accepted ethical standards surrounding the use of human subjects that have their origin in the Declaration of Helsinki.

According to ISO 14155 and the MDR, the sponsor shall implement and maintain written quality procedures to ensure that the clinical investigation is designed, conducted and reported in compliance with ISO 14155, the clinical investigation plan (CIP), any subsequent amendments, and any other applicable standards and regulatory requirements.

Establishing and maintaining a clinical Quality Management System (QMS) is resource intensive work that requires in-depth knowledge. By licensing or purchasing our clinical QMS you receive access to an ISO 14155-customized QMS which has been audited by an external auditor as well as EU and US based clients.

Performance Study

The new In Vitro Diagnostics Regulation (IVDR 2017/746) contains considerable detail on the planning and reporting of clinical performance studies. Let Kickfile’s systems provide you with the tools you need to ensure that you have compliant systems in place for your study.

The purpose of clinical performance studies is to establish or confirm aspects of device performance which cannot be determined by analytical performance studies, literature and/or previous experience gained by routine diagnostic testing. This information is used to demonstrate compliance with the relevant general safety and performance requirements with respect to clinical performance. When clinical performance studies are conducted, the data obtained shall be used in the performance evaluation process and be part of the clinical evidence for the device.

The IVDR includes requirements applying to performance studies, including but not limited to; requirements for studies which obtaining specimens poses a particular risk for the subject, requirements for reporting adverse event occurring in a performance study, requirements for performance studies involving vulnerable subjects.

Post-Market Surveillance and Post-Market Performance Follow-up

The new In Vitro Diagnostics Regulation (IVDR 2017/746) places greater emphasis on PMS and PMPF. Whereof the latter shall be understood to be a continuous process that updates the performance evaluation and shall be addressed in the PMS plan. It is important to note, however, that the requirement for PMPF under the IVDR does not necessarily means that post-market clinical performance studies will be required in all cases to collect safety, performance and scientific data.

Kickfile’s system can be used for creating PMS and PMCF plans, reports and other necessary documentation as well as for updating your performance evaluation documentation.

Post-Market Surveillance and Post-Market Clinical Follow-up

The new Medical Device Regulation (MDR 2017/745) places greater emphasis on PMS and PMCF. Whereof the latter shall be understood to be a continuous process that updates the clinical evaluation and shall be addressed in the PMS plan. It is important to note, however, that the requirement for PMCF under the MDR does not necessarily means that clinical investigations will be required in all cases to collect clinical data. Under the MDR, the definition is much broader and related to all type of clinical information.

Kickfile’s system can be used for creating PMS and PMCF plans, reports and other necessary documentation as well as for updating your clinical evaluation documentation.

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