Quality Management System
With the right system safely through the EN ISO 13485 audit
If Quality Management is understood and lived, not only can the audit be passed; time, costs and nerves can also be saved.
Challenges in Quality Management
Your QMS is confusing and chaotic, and is missing improvements? The standards say: You must... but you don't know how?
The requirements were patched-up for the last audit and you got off with a slap on the wrist? Then the issues are left aside and the next audit is due, and when the time comes, you hear things such as:
- CEO: “It worked last time!” or “That has never been noticed in an audit. Why is it an issue now?”
- Product Manager: “The device is in development and must be placed on the market.”
- Developer: “The auditors are asking too much and have little knowledge of development.”
- Production Employee: “Do I really have to document all this?”
- Department Manager: “The audit should not disrupt.”
qtec as your partner
Our approach to a realistic process is:
- Reliable customer-oriented and lean processes that meet the international requirements
- Understanding the customer and their procedures
- Implementing or adapting processes that conform to standards
- Clear responsibilities
- Embedded in a clean process landscape
- Create understanding and acceptance among the employees who live the process every day
The best and fastest development in the world is useless if the Medical Devices cannot be manufactured with quality. Only Medical Devices with high merit bring safety, positive performance, and customer satisfaction. Therefore, Quality Management and Quality Assurance for Medical Devices is a strictly regulated area that is constantly changing. But not only development and manufacturing have to work together. Purchasing, Human Resources, the Post-Market Surveillance department, and ultimately the management must also be integrated into the QMS and provide important aspects for maintaining the QMS and product quality.
Individual solutions ensure a successful implementation that can be lived and is compliant. Here it does not matter whether you are a
- 1-man company
- large corporation
- Manufacturer for non-active class I products
- Manufacturer of active class III products
Our experts for QM Systems and auditors know what is important and how a process can be tailored to your company. Whether EN ISO 13485, EN ISO 9001, QSR (21 CFR 820), GMP, GLP, (EU) 2017/745, (EU) 2017/746, etc.
- Which clinical strategy do I use to evaluate my software as a medical device according to MDCG 2020-1? We know the regulatory requirements.
- Areas: Europe, Worldwide / Updates, New regulations and guidances 31/22
- Life Cycle management tool support in medical technology. DOORS, RQM or ELM - correctly manage requirements, tests, documentation and traceability.
- Areas: Europe, Worldwide / Updates, New regulations and guidances 20/22