Quality management consulting on the EU regulations (MDR/IVDR) and ISO 13485:2016
- Quality management outsourcing (internal audits, supplier audits, observers during inspections and audits by notified bodies, CAPA implementation following non-conformities, employee trainingraining)
- Implementation of your quality management systems
- Ongoing advice and support to improve your quality management system (management review support), SWOT analyses, continuous improvement process, CIP, training, etc.)
- Extensive know-how from experts in the field
A successful and well-thought-out quality management system (QMS) is the basis for growth and a successful company. The medical device industry is heavily regulated – these provisions relating to the EU MDR/IVDR regulations in combination with the ISO 13485 quality management standard mean a considerable amount of personnel work for medical device manufacturers.
We at en.co.tec have set ourselves the goal of making implementation and management easier for you in order to meet the high requirements. We work with you to develop a customized solution for your specific quality management task in your company. From introduction to certification, we support our customers throughout the entire quality management process.
Our consultants are your guides – they know the route and the risks, and will get you safely and professionally to your destination. Our consulting approach aims to empower you to implement viable solutions in your internal management yourself. In our opinion, this is the more sustainable and therefore more cost-effective way in the long term than implementing a standard solution “imposed” from outside.
We have the right quality management solutions for you
At en.co.tec, you and your quality managementsystems, as well as your medical devices, are at the center of our consulting services. We offer advice on your quality management and many related areas:
- Quality management requirements of the EU regulations (MDR/IVDR) and ISO 13485 (possibly in combination with ISO 9001)
- Quality System Regulation (US-FDA), Medical Device Single Audit Program (MDSAP)
- Product-specific QMS requirements such as risk management (ISO 14971), suitability for use (EN 62366-1) or software life cycle (EN 62304).
3 steps to your optimized quality management
Regardless of whether you already have a quality management system (QMS) in your company, e.g. in accordance with ISO 9001, or whether we are introducing a quality management system together – in three simple steps, we provide you with individual support to meet the quality management requirements of the EU regulations (MDR/IVDR) and/or ISO 13485 right from the start. No bloated documentation – just exactly what you need.
- Inventory and introduction
Once you have decided on a system, our professional consultants will support you in analyzing, implementing and documenting your quality management system processes. - Auditing
The QMS created is checked by an independent en.cotec auditor as part of an internal audit. If you already have an existing QM in your company, the review will take the form of an internal audit. - Certification
We take care of the certification body (ISO 13485) and / or the notified body (EU regulations (MDR/IVDR)), accompany you through the stage 1 audit and the certification audit.
Further advice
Once your quality management system certificate has been issued, we will be happy to support you with “3-year-around-happy” offers for maintaining your quality management system with internal audits and heavily discounted priority access to our consulting and training services.
The first audit for your optimized quality management
Every good consultation starts with an initial audit, i.e. an analysis of your current status in relation to the requirements of the EU regulations (MDR/IVDR) and ISO 13485 (possibly in combination with ISO 9001). We examine existing structures and processes and use the audit to identify both the need for action and unused potential.
Practical relevance plays the biggest role in the audit. All of our consultants are certified internal auditors and have at least 5 (but usually 10+) years of experience in a managerial role in the field of quality management and/or regulatory affairs. This means that we are often more experienced than our counterparts from the notified bodies. This gives you the best possible support for your optimized quality management!
Our training courses & events
If you want to take quality management in your company into your own hands, then attend one of our training courses. Here you will learn how to successfully implement the QMS in your company and benefit from the practical knowledge of our professionals during the training – we look forward to hearing from you!
The advantages of consulting for your optimized quality management are manifold. Here you can get a clear overview of your benefits:
- Ongoing advice and monitoring
If you opt for quality management consulting from en.co.tec, you will benefit from our experts’ trained, independent and external view of your quality management system. - High quality standard
All our consultants are certified internal auditors. Our audits are carried out exclusively in accordance with ISO 19011, the “Guide to auditing management systems”. - Creates long-term resources
Our support for your quality management system creates or relieves the necessary personnel resources and skills in the long term. This gives you more time and energy for your core tasks and guarantees that your quality management system runs smoothly. - Long-term cost reduction
In our view, the most important QM process is the “corrective and preventive action” process. It aims to prevent the (re-)occurrence of errors. This not only relieves your employees of annoying firefighting actions, but also saves on follow-up costs. - Practice-oriented know-how
Our consultants come from the field and have at least 5 (but usually 10+) years of experience in a managerial role in the area of quality management and/or regulatory affairs. During the first audit, you will gain an impression of our experts’ broad field of expertise.
Our references
We have already worked with many companies and experts in the field of quality management – here you will find an overview of our references:
Do you also need advice on optimizing your quality management? Then get in touch with us – you can register online for an initial consultation or take part in our training course! We look forward to seeing you!
