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eTD Medica Devices

Technical Documentation is the basis for a successful conformity assessment procedure and is therefore crucial on the way to approval of your Medical Device.

BAYOOSOFT Themis is your validated solution for all documentation processes relating to Medical Devices and In-Vitro-Diagnostics. Digitize linked processes and sustainably reduce documentation efforts while minimizing redundant data.

BAYOOSOFT Themis assists you in the following processes for creating technical documentation:

Product Packages for Manufacturers of Medical Devices (and In-Vitro Diagnostics)

Themis Documentation Guide

The Documentation Guide complies with the requirements of

  • MDR 2017/745 Annex II Technical Documentation
  • IVDR 2017/746 Annex II _Technical Documentation__

The taskbased approach ensures that your Medical Devices meet all the requirements of these regulations.

Use the following documents in the Documentation Guide:

  • MDR Technical Documentaiton
  • IVDR Technical Documentation

Requirements Pack

Requirements Management is an important part of the efficient and error-free development of complex Medical Devices and is particularly important for complex product and system concepts and development based on division of labor. In addition to the definition and implementation of processes, the traceability of all specific requirements over the entire product life cycle must also be covered and the requirements verified and validated accordingly.

The Requirements Pack helps you to manage all requirements for your Medical Device in a clear, structured and centralized manner.

Cover the following requirements with the Requirements Pack:

  • Requirements Engineering (acc. IEC 62304)
  • MDR 2017/745 Annex I General Safety and Performance Requirements
  • IVDR 2017/746 Annex II General Safety and Performance Requirements
  • Canadian Medical Device Regulation (SOR/98-282) Safety and Effectiveness Requirements
  • Australian Therapeutic Goods (Medical Devices) Regulations 2002 - Essential Principles

Risk Pack

A Medical Device is used on or inside patients and involves a certain degree of risk. Here, a particularly high level of protection is required. Any residual risk must therefore be weighed up against the benefits of the device. Internationally, risk management for Medical Devices and In-Vitro Diagnostics is therefore consistently required.

The international valid standard ISO 14971 stipulates a procedure to this end, which identifies the hazards associated with Medical Devices and their accessories, assesses, rates and controls the risks and monitors the effectiveness of these controls.

The BAYOOSOFT Themis Risk Pack enables you to record all relevant information in a clearly structured environment, store it centrally in an audit-proof manner and link it dynamically at a fine granular level.

The Risk Pack offers you the following evaluation procedures:

  • Preliminary Hazard Analysis (PHA): The aim of this procedure is to identify safety-critical areas at an early stage, deliver initial hazard assessments and define necessary and appropriate hazard controls and subsequent measures. Since it is used both as part of the requirements analysis as well as in the early phases of the design process for your Medical Device, this provides a relatively early start to risk management in the entire lifecycle and supports you in identifying risks at an early stage and efficiently considering measures in the development process on this basis.

The following documents are included in the Risk Pack:

  • Risk Management Plan
  • Risk Analysis, Evaluation and Risk Control
  • Overall Residual Risk
  • Risk Management Review
  • Post Production Activities

Device Validation Pack (coming soon)

Your fast track to the release of your Medical Device: Plan and document all your tests centrally in a single source.

Currently, support for the following validation processes is planned:

  • Usability Engineering acc. to EN 62366 and IEC EN 60601-1-6
  • Clinical Evaluation acc. to MDR 2017/745
  • Performance Evaluation acc. to IVDR 2017/746

Software Validation acc. to DIN EN ISO 13485

According to DIN EN ISO 13485, all systems involved in the process must be validated. BAYOOSOFT Themis has undergone a validation process in accordance with GAMP 5 - Guideline for computer-aided validation and is validated accordingly.

If you are using the hosted version of BAYOOSOFT Themis, we ensure the validation of this environment. This involves a full software validation once a year. In addition to the sprint acceptance tests, a performance qualification (PQ) is conducted for all software releases in between. The purpose of these tests is to continuously prove that the system still meets the requirements, technical specifications and evaluation criteria of the software validation. The results of this performance qualification can be viewed in the release approval of the respective release.

If you have opted for on premise, we will be happy to provide you with predefined forms for validating BAYOOSOFT Themis in your infrastructure. Therefore, please contact our Service Team.