F E A T U R E S

that really matter for you

(1) Standards Database

medifiler includes a database of more than 400 harmonized and recognized standards. Beside ISO and EN standards, we have included relevant ASTM standards related to testing and material verification.

The first release will include bibliographic data only while we plan to include more content in the subsequent app releases.

(2) Annex I: General Safety and Performance Requirements

The General Safety and Performance Requirements (GSPR) must be evaluated for their applicability for the specific device. We provide support to simplify the evaluation with guidance, give access to the internal standards database and enable direct links to the technical file of the device.

(3) Annex II: Technical File

The Annex II module of medifiler allows simple and powerful control of technical documents including search functions, document lists and revision tracking. You can even upload documents into the tool with preview functions and easy export.

(4) Annex III: Post-market Surveillance Documentation

Once the device is placed on the market, post-market surveillance must actively been executed. The MDR and the IVDR requires several documents to be prepared such as a PMS Plan, PMS Reports and Periodic Safety Update Reports. Relevant information must be collected and analyzed.

(5) Annex VI: UDI

Unique device identification (UDI) must be defined for any new device. The European Commission has published numerous documents with helpful information. We translated complex content into plain description. This module helps to define the UDI and Eudamed data for any medical device.

(6) Annex VIII: Device Classification

Both regulations (MDR and IVDR) require that a risk classification of the medical device is conducted and documented. Our annex VIII module gives guidance and supports the classification process - easy and simple.

(7) Guidance Documents

All MDCG (Medical Device Coordination Group) documents and other guidances will be included. With export function, helpful summaries and always updated.

(8) MDR Full Text

Helpful and always easy accessible: the full text of the MDR (EU) 2017/745.

(9) IVDR Full Text

Also included: the complete text of the IVDR (EU) 2017/746 for fast access during daily routine.

(10) Development Process Map

Our favorite tool for project planning: a visual map of typical development phases with all mandatory deliverables.

(11) Annex XIII: Performance Evaluation for IVD Devices

Useful checklists and templates to fill. Direct export as PDF documents of Performance Evaluation Plans, Scientific Validity Reports, Analytical Performance Reports, Clinical Performance Report and a comprehensive Performance Evaluation Report.

(12) Annex XIV: Clinical Evaluation for Medical Devices

Preparing the documents for the clinical evaluation of medical devices is time consuming and is highly dependent on proper input and structures. medifiler provides guidance documents and digital forms for easy document preparation.