Presentation of Qualitiso Templates


Medical device manufacturers:
The solution for your
regulatory and quality affairs!

  • Build your Quality System
  • Manage the Technical Documentation of your products
  • Achieve the CE marking of your medical devices
  • Follow the news and developments in the industry
  • Take advantage of a tailored offering and stay in step with regulatory and standards developments
  • templates, requirements covered, parameters, examples, commentary and definitions
👉 Click to view list of Qualitiso templates!

Name Family
⚙️ Settings Settings
❔ Tuto General
📰 Watch – Web Watch
📰 Watch – ISO Watch
📰 Watch – Drafts Watch
🗺️ Eudamed Map Databases
🗃️ Reg. Databases
🗃️ Templates Databases
🗃️ Docs Databases
🗃️ Standards Databases
🗃️ Notified Bodies Databases
🗃️ Adverse Reactions – IMDRF
🗃️ Dictionary
🏛️ EU Regulation 2017/745 Regulation (EU) 2017/745
🏛️ Class (Annex VIII) Regulation (EU) 2017/745
🗃️ MD codes Regulation (EU) 2017/745
▶️ Procedure – Transition to the MD Regulation Regulation (EU) 2017/745
▶️ Procedure – Management of Normative and Regulatory Requirements Regulation (EU) 2017/745
▶️ Procedure – Post-Marketing Surveillance (PMS) Regulation (EU) 2017/745
▶️ Procedure – Vigilance Regulation (EU) 2017/745
❎ General Security and Performance Requirements (Annex I) Regulation (EU) 2017/745
📅 Plan – Post-Marketing Surveillance (PMS) Regulation (EU) 2017/745
📓 File – Summary of Technical Documentation (TD) Regulation (EU) 2017/745
📓 Report – Periodic Safety Update Report (PSUR) Regulation (EU) 2017/745
📓 Report – Post-Market Surveillance (PMS) Regulation (EU) 2017/745
▶️ Procedure – Purchasing Management Quality System
▶️ Procedure – Risk Approach
▶️ Procedure – Audits Quality System
▶️ Procedure – Regulatory Communications and Records Management
▶️ Procedure – Design and Development Quality System
▶️ Procedure – Document Management
▶️ Procedure – Measurement and Control Equipment Management
▶️ Procedure – Customer Requirements Management Quality System
▶️ Procedure – Change Management
▶️ Procedure – Human Resource Management Quality System
▶️ Procedure – Identification and Traceability Quality System
▶️ Procedure – Infrastructure and Work Environment
▶️ Procedure – Marketing and Customer Sales Contact
▶️ Procedure – Measurement, Analysis and Improvement Quality System
▶️ Procedure – Non Conformities and Preventive and Corrective Actions (NC, CAPA)
▶️ Procedure – Production and Service Delivery
▶️ Procedure – Management Reviews
▶️ Procedure – After Sales Service
▶️ Procedure – Production Validation Quality System
▶️ Procedure – Validation of Software Used by the Company
❎ Specification – Device
📅 Plan – Design and Development
🔎 Reviews – Design and Development
📄 Document – Follow-up Actions
📄 Non Conformities and Corrective and Preventive Actions (NC, CAPA)
📄 Quality Manual
❎ Requirements – Information Provided (IFU)
❎ Requirements – Labeling
▶️ Procedure – Benefit/Risk (B/R) Analysis Risk Management
▶️ Procedure – Risk Management Risk Management
▶️ Procedure – Cybersecurity Management Risk Management
📅 Plan – Risk Management Risk Management
🔎 Reviews – Risk Management Risk Management
📓 File – Risk Management Risk Management
📄 Document – Risk Analysis (Software Item) Risk Management
▶️ Procedure – Usability Engineering (Usability Engineering, IEC 62366-1) Ability-to-use
📅 Plan – Usability Engineering (Usability Engineering) Ability to Use
🔎 Reviews – Usability Engineering (Usability Engineering) Ability to Use
📓 Report – Usability Engineering (Usability Engineering) Ability to Use
▶️ Procedure – Biological Evaluation (10993)
📅 Plan – Biological Evaluation Biological Evaluation
📓 Report – Biological Evaluation
▶️ Procedure – Clinical Evaluation Clinical Evaluation
▶️ Procedure – Literature Search for Clinical Evaluation
▶️ Procedure – Post-Market Clinical Follow-up (PMCF)
📅 Plan – Clinical Evaluation
📅 Plan – Post-Market Clinical Follow-up (PMCF)
📓 Report – Clinical Evaluation Clinical Evaluation
📓 Report – Post-Market Clinical Follow-up (PMCF)
▶️ Procedure – Electrical Security (60601-1) Electrical Security
❎ Requirements – Electrical Security (60601-1) Electrical Security
▶️ Procedure – Software Life Cycle (IEC 62304)
❎ Specification – Software Architecture (SSA) Software
❎ Specification – Software Configuration File Software
❎ Specification – Software Requirements (SSR) Software
❎ Specification – Software Units (SSU) Software
📅 Plan – Software Development Software
📅 Plan – Software Testing (STP) Software
🔎 Reviews – Software Life Cycle Management Software
📓 Report – Software Testing Software
📓 File – IMDRF Regulatory Submission Other Regulations
📓 File – Instructions for Use provided in Electronic Format (e-IFU)
📄 Declarations under Directive 93/42/EEC

Master the regulatory environment

Manufacturers
  • Transitioning to the MD regulation
  • Consolidating your QMS
  • Staying current with new developments
  • Respond to non-conformities
Start-ups
  • Integrating MD industry requirements
  • Build a quality system
  • Implement applicable standards
  • Create technical documentation for your devices
Consultants
  • Work with a comprehensive, up-to-date, and consistent system
  • Take advantage of collegial expertise
  • Meet customer needs with online tools
  • Staying in step with industry developments

Integrate medical device requirements

MD regulations
Regulation (EU) 2017/745

Quality System
ISO 13485

Risk Management
ISO 14971, XP S99-223

Usability
IEC 62366-1

Biological evaluation
Regulation 2017/745, ISO 10993-x

Clinical evaluation
Regulation 2017/745, MDCG and Meddev Guides

Software and Cybersecurity
Regulation 2017/745, IEC 62304+A1, MDCG Guides

Electrical security
IEC 60601-1+A1

User information
Regulation 2017/745, ISO 15223-1, EN 1041, ISO 20716, MDCG Guides

and more!
Watch, Regulations, Standards, Guides, Regulation 207/2012…

F.A.Q

Can I get my devices certified with Qualitiso templates?

Yes, the templates allow you to complete the CE-marking of a medical device, obtain ISO 13485 certification, and ensure device monitoring, as long as you put in the effort to understand and implement!

What are your commitments?

The templates brings a response to each requirement of the claimed repositories, this has been reviewed requirement by requirement
2. The templates are continuously improved, as user feedback and regulatory and normative changes are made.

I am new to the medical device context, can I use Qualitiso templates?

Yes, notes and examples accompany the templates, they are intended for beginners who do not have much experience in the sector.
A tutorial is available, advising you on the order of implementation of the procedures and documents.

How long does it take to implement a QMS using Qualitiso templates?

It will typically take 6 to 18 months, depending on the resources you devote to it, the level of risk in your device and its complexity. In any case, Qualitiso templates will help you speed up the regulatory conformity process.

Are Qualitiso templates available in English and French?

Yes, you can switch from one language to another directly from the interface.

Does the subscription price remain fixed after subscription?

Yes, the price of a subscription remains fixed until terminated.
Rate increases, applicable only to new subscriptions, are planned as new templates are created.

How are payments made?

Two payment options are available:
1. by credit card, debited monthly, or
2. by wire transfer, made semi-annually

Is the system cross-browser compatible?

Yes, but for best performance, it is recommended to use a Chromium-based browser (Chrome, Edge, Opera, Brave…).

Has your system proved itself?

Yes 🙂 since 2019 are more than 150 companies and experts who have been able to complete their projects thanks to Qualitiso templates!