MedTech compliance made easy

With Kickfile, you get access to the systems you need for putting a medical device on the market – in a compliant and predictable way.

 

  • Instant
  • Accurate
  • Flexible
MedicalDevice_Compliance

What is Kickfile?

A cloud-based document system supporting compliance for medical devices, IVD products, cosmetics & pharma. All processes, templates and forms needed for market access are aligned and updated according to the latest regulations and standards. In other words, everything you need for a more predictable way to market.

Why compliance?

In order to reach the market – compliance with laws and regulations is a must for medtech and pharmaceutical products. Regulatory bodies require traceable processes and documentation to ensure quality, performance, efficacy, and safety.  Kickfile provides just the right documents and processes needed to get your product on the market and support you during an audit. Instant, accurate, and flexible.

How it works

Get the tools for a smooth and accurate compliance process.

1.   Start by specifying product category and areas of interest

2.  Choose access type

3.  Request a quote

4.  Download all files required

5.  Ready to start

Workflow example

Kickfile offer support with e.g.

Clinical Evaluation

Whether you are developing a new medical device, or need to update an existing clinical evaluation, Kickfile’s system provides you with the tools you need to ensure compliance with MEDDEV 2.7/1 Rev4 and MDR 2017/745.

Clinical evaluation ensures the safety and performance of a medical device. It is an ongoing process to collect, appraise and analyze clinical data throughout the life cycle of a medical device. 

Whether you are developing a new medical device, or need to update your clinical evaluation, Kickfile’s system provides you with the tools you need to ensure compliance with MEDDEV 2.7/1 Rev4 and MDR 2017/745.

 

Example of material:

  • Clinical Evaluation Procedure
  • Clinical Evaluation Plan Template
  • Clinical Evaluation Report Template
  • Clinical Development Plan Template
  • Information Search Protocol Template
  • Information Search Report Template
  • State-of-the-Art Report Template
  • Summary of Safety and Clinical Performance Template

 

Clinical Investigation

According to ISO 14155 and MDR 2017/745 the Sponsor must implement and maintain written quality procedures to ensure that the clinical investigation is designed, conducted and reported in a compliant manner.

Through Kickfile you access validated systems for all types of clinical investigations, e.g. company sponsored as well as investigator initiated investigations.

Example of material: 

  • 17 Procedures, incl. Site Selection, Informed Consent, Monitoring, and Safety Reporting.
  • 34 Templates, incl. Clinical Investigation Plan, Investigator’s Brochure, Monitoring Plan, Clinical Investigation Report, Study Master File Index, and Monitoring Visit Report.

 

 

Post-market Surveillance

Regardless of medical device type or class you will need to have a dedicated PMS system to collect and review experiences gained from the device once placed on the market.

Kickfile’s systems can be used for creating PMS and PMCF plans, reports and other necessary documentation. The systems are always up to date with the latest regulations and guidelines and can be customized for your product and company.

Example of material: 

  • Post-Market Surveillance Procedure
  • Post-Market Clinical Follow-up Procedure
  • PMS Plan Template
  • PMCF Plan Template
  • PMS Report Template
  • PSUR Template
  • PMCF Evaluation Report Template

 

Usability
Biological Evaluation
Risk Management
Medical_Devices_Compliance

Kickfile offer support with e.g.

Perfomance Evaluation

Performance Evaluation means the assessment and analysis of data to establish or verify scientific validity, analytical performance, and clinical performance of a device. According to the IVDR 2017/746, clinical evidence must support the intended purpose of the device and be based on a continuous process of performance evaluation.

Whether you are developing a new device or need to update your performance evaluation, Kickfile’s system provides you with the tools that you need to ensure compliance with the IVDR 2017/746.

Example of material:

  • Performance Evaluation Procedure
  • Performance Evaluation Plan Template
  • Performance Evaluation Report Template
  • Information Search Protocol Template
  • Information Search Report Template
  • State-of-the-Art Report Template
  • Scientific Validity Report Template
  • Analytical Performance Report Template
  • Clinical Performance Report Template
  • Summary of Safety and Clinical Performance Template

 

Clinical Performance Study

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

Through Kickfile you can access validated systems for all types of performance studies.

Example of material:

  •  17 Procedures
  • 34 Templates
Post-Market Surveillance

The new IVDR 2017/746 places greater emphasis on Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (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.

Kickfile’s system can be used for creating PMS and PMPF plans, reports and other necessary documentation.

Example of material:

  • Post-Market Surveillance Procedure
  • Post-Market Performance Follow-up Procedure
  • PMS Plan Template
  • PMPF Plan Template
  • PMS Report Template
  • PSUR Report Template
  • PMPF Report Template

 

Usability
Biological Evaluation
Risk Management
InVitroDiagnostics

Medical Device Software

 Software is a medical device if the intended use falls into the scope of the current medical devices regulations, MDR 2017/745 or IVDR 2017/746. Through Kickfile you can gain access to systems that have been optimized to fulfill the requirements for Medical Device Softwares.

 

Kickfile offer support with e.g.:

  • Clinical Evaluation / Performance Evaluation
  • Clinical Investigation / Clinical Performance Study
  • Post-Market Surveillance
  • Usability
  • Risk Management

For more information related to the services please see the Medical Devices section and In Vitro Diagnostics section or contact us.

 

MedicalDeviceSoftware

Combination Products

Regardless if you have an integral or a co-packed combination. Kickfile’s systems facilitate your compliance efforts.

Kickfile offer support with e.g.: 

  • Clinical Evaluation
  • Clinical Investigation
  • Post-Market Surveillance
  • Usability
  • Biological Evaluation

For more information please see the Medical Devices section.

Pharmaceuticals

Phase I to Phase IV Clinical Trials

Regardless of the reasons for initiating a trial, it comprise of a wide spread process and comprehensive regulatory framework. 

Let Kickfile’s system guide you through all the steps needed for your clinical trial and make your journey from study idea to fully executed investigation swift, transparent and agile.

 

Monitoring

Adequate monitoring through out clinical trials is crucial and guarantees subject welfare, data quality and compliance. Kickfile offers customized monitoring services for all phases and types of clinical trials.

 

Cosmetics

 

The definition of medical devices covered under the MDR 2017/745 will be significantly expanded to include devices without a medical intended purpose, such as colored contact lenses, cosmetic implants, subcutaneous fillers. For these devices, the same May 2021 deadline applies as for other medical devices.

Whether your cosmetic product will fall under the new extended definition of a medical device, or you want to explore the possibility to transform a currently marketed medical device to a cosmetic product, Kickfile’s system can help you navigate regulatory requirements.

Kickfile offers support with e.g.:

  • Product Information File
  • Market Study

The compliance ecosystem

The Kickfile systems cover every step of the complex compliance ecosystem. You get support and guidance to the right strategies, structures and documents – making your process faster and more accurate.

Kickfile_Compliance

“We established Kickfile to make it easy to become and stay compliant.”

Sofia Nordgren

CEO Kickfile AB

Why Kickfile?

With Kickfile you always have up-to-date documents and processes for a faster and more predictable market access.

Instant Access

With our cloud-based tools you get immediate access to everything you need.

Accurate and proved

Our systems have been audited by external auditors and used operationally for several years.

Flexible

Only pay for what you need when you need it.

Unmatched expertise

Our experts educate notified bodies and take part in the working groups writing international standard for medical devices and IVD products.

Professional support

Through our network you gain access to some of the most experienced MedTech experts available.

Up to date

Through our systems you get access to the latest and most accurate documents.

News & Whitepapers

Partners for full service

Together we support all your needs, everywhere, every time. Irrespective if it relates to Strategic Advice, Quality Assurance, Regulatory Affairs, Clinical Affairs or Biocompatibility..

Configure your own compliance system