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Stay compliant.
Use our update service and stay compliant with regulatory requirements. You can either purchase the latest version or use our update service. It updates your documents at regular intervals ensuring that you always remain compliant with regulatory requirements. We offer compliance updates in the quality management system, regulatory and vigilance areas.
Quality Management System QMS 5.0
The regular services QMS 5.0 quality management system is a complete quality management system for medical device manufacturers. QMS 5.0 can be fully implemented or used as a reference system for your organization’s existing quality management system. Regular updates ensure that your quality management system meets current regulatory requirements.
QMS 5.0 Basic Package
The regular services quality management system QMS 5.0 consists of a basic package and optional standard operating procedures. The basic package contains a quality management manual and all standard operating procedures that manufacturers must implement. The basic package can be extended with optional standard operating procedures depending on the type of product or marketing area (e.g., “standard operating procedure Software Development” or “standard operating procedure Vigilance System USA” procedure instruction, etc.). Standard operating procedures include all required templates and documents for recording data.
The regular services quality management system QMS 5.0 consists of a basic package as well as optional extras. The QMS 5.0 basic package covers the following Regulations:
- EN ISO 13485:2016/AC 2016
- ISO 13485:2016
- EN ISO 14971:2012
- 93/42/EWG
- 90/385/EWG
- German Medical Devices Act (MPG)
- German Medical Devices Safety Regulations (MPSV)
- European and international QMS guidelines
- MEDDEV 2.7.1 Rev. 4 (Clinical evaluation: Guide for manufacturers and notified bodies)
- MEDDEV 2.12/1 Rev. 8 (Guidelines on a Medical Devices Vigilance System)
- US 21CFR820 (QSR)
- Regulation (EU) 2017/745 (MDR)
QMS 5.0 Options
The basic package may be enhanced with optional procedural instructions depending on the nature of your medical devices (active medical devices, non-active medical devices, medical devices with patient contact, etc.) and marketing areas (e.g., “Standard Operating Procedure Software Development” or “Standard Operating Procedure Vigilance System Canada”, etc.).
QMS 5.0 Updates
QMS 5.0 updates are offered quarterly based on the package and options purchased. The updates include the complete implementation of new or amended regulatory requirements. The changed procedural instructions and affected templates are simply replaced. In addition to the changes required by regulatory requirements, insights from best practice methods are considered.
Time-consuming research and incorporation of changed and new regulatory requirements is completely eliminated, and your organization is always up to date.
Ready to Use
QMS 5.0 contains all the required process steps in an easy-to-understand manner. Additionally, employees are ‘guided’ by templates, resulting in the ‚automatic‘ creation of documents and records which complies with regulatory requirements
Instruction and How-Casts (Training videos)
In addition to a personal briefing by our employees, a variety of How-Casts (training videos) are offered for QMS 5.0. How-Casts explain how to complete QMS 5.0 templates and forms, and provide facts to take into consideration. How-Casts can be viewed by employees as often as they like. How-Casts are offered in German and English.
regular services QMS 5.0 Basic Package
| Standard Operating Procedures (inclusive of forms and templates) | |
|---|---|
Basic package | Quality Management Manual |
| Document Control | |
| Control of Regulations | |
| QMS-Software-Validation | |
| Management Review | |
| Quality Management System Planning | |
| Human Resources and Training | |
| Design Control | |
| Risk Management | |
| Process Validation | |
| Verification-Validation | |
| Translation-Labeling | |
| Marketing Authorization | |
| Production | |
| Supplier Management | |
| Purchasing | |
| Control of Measuring and Test Equipment and Facilities | |
| Clinical Evaluation Management | |
| Order Processing Medical Device | |
| CASE Management (Change Management) | |
| Corrective and Preventive Actions (CAPA) | |
| Complaints | |
| Control of Nonconforming Products | |
| Internal Audits | |
| External Audits and Inspections | |
| Data Analysis | |
| Post-Market Surveillance | |
| Vigilance System |
regular services QMS 5.0 Options
| Standard Operating Procedures (inclusive of forms and templates) | |
|---|---|
Options | Marketing Authorization CE |
| Marketing Authorization USA | |
| Marketing Authorization Canada | |
| Marketing Authorization ROW | |
| Software Development | |
| Manufacturing Process Development | |
| Returned Products and Contaminated Products | |
| Clinical Evaluation | |
| Biological Evaluation | |
| Repair and Maintenance | |
| Vigilance system CE | |
| Vigilance System USA | |
| Vigilance System Canada | |
| Vigilance System ROW |
Please feel free to contact us. We will gladly email you a comprehensive description of our regular services quality management system QMS 5.0
Regulations Updates
The regular services Regulations Update Service ensures that the list of regulations applicable to your organization is up-to-date and complete at all times.
The Regulations Update Service includes the following services:
- Search of applicable Regulations
(Regulations refer to Standards, Common Specifications, Laws, Regulations, Directives, Implementing Acts, Guidelines and Recommendations) - Verification of the relevance of the Regulations
- Identification of content changes (GAP- analyses) in applicable Regulations
- Assistance in evaluation of changes to applicable Regulations
We offer the Regulations Update Service for the following marketing areas:
- International: ISO, IEC and IMDRF (formerly GHTF) standards and regulations to assist in the identification of “State of the Art”
- CE area
- USA
- Canada
- Taiwan
We are also able to assist you in other marketing areas upon request.
The Regulations Update Service has a modular structure and can be extended at any time.
Please feel free to contact us. We will gladly email you a comprehensive description of our regular services regulations updates.
Vigilance Updates
With the regular services Vigilance Update Service, you ensure that current vigilance requirements of selected target markets are taken into account in your quality management system. Vigilance requirements are internationally harmonized to a limited extent only. Both the definitions and regulatory requirements for reporting “incidents” and “recalls”, differ significantly. For an internationally operating organization, the search for currently valid vigilance requirements is therefore very time-consuming. Like almost all regulatory requirements, vigilance requirements are subject to constant change.
The regular services Vigilance Update Service assists you in identifying and updating the legal requirements for vigilance requirements. The Vigilance Update Service includes the following services:
- Research of relevant legal requirements of the target markets
- Verification of the relevance of the legal requirements
- Identification of content changes
We offer the Vigilance Update Service for worldwide marketing countries. The vigilance update service has a modular structure and can be extended at any time.
Please feel free to contact us. We will gladly email you a comprehensive description of our regular services vigilance updates.