We prepare clinical evaluations according EU MDR 2017/745.
Preparation of clinical evaluations
Preparation of clinical evaluations according to EU MDR 2017/745.
Medical device approval
The approval of medical devices in Europe according to EU MDR 2017/745 or other regulations, e.g. USA according to 21 CFR 820, is a complex process and requires a lot of expertise about the medical device in question, its classification, its life cycle from development, through production, to use and disposal. Approval of a medical device involves a large number of steps and the associated documentation. We help you with all steps of the product approval process. You decide how much help you want to take advantage of and decide on the scale from a simple consulting meeting to the complete takeover of the entire approval process.
Conformity assessment procedure
We accompany your development projects, conformity assessment procedures and support you in working with notified bodies and authorities.
Risk management
EN ISO 14971 – Risk management for medical devices
Risk management covers the entire life cycle of a medical device from the individual phases of development, through the individual steps of production, storage, transport, use and disposal. This includes the steps of risk definition, risk evaluation and the definition of risk reduction through appropriate measures. We show you how to optimize your risk management.
We show you, how you can optimize your risk management.
Risk management files
We create your risk management files according EN ISO 14971.
STEIN HEALTHCARE PROJECTS
You can receive support from us in all questions relating to the conformity of medical devices in Switzerland, the EU, the MDSAP countries US, CAN, BR, AUS, JP and other countries.
We advise you “Made in Swiss!”
Quality management
EN ISO 13485 – Quality management for medical devices
Quality management is more than just an ISO standard or a manual. It is the right process analysis and the Definition of the objectives as well as the strategic direction of the company and their implementation. QM is closely associated with the corporate strategy, direction of the company and business success. Often is the management through sophisticated business develop in a blindness for needs and the timing of a decision. In a position, such as quality management, it has the advantage of cross-departmental activity and to related information, as well as an often closer contact with the staff. It is precisely for this reason your staff unit for management of benefit to listen and to take the statements about the company seriously.
Quality management system for medical devices
Do you need the introduction and / or maintenance of a quality management system for medical devices?
We have years of experience in this area.
Approval of medical devices
EU MDR 2017/745 – Approval of medical devices in Europe