
Industries
Pharmaceutical Manufacturing
Our original solution.
In the pharmaceutical manufacturing industry, Quality Management Review (QMR) is a government regulated process designed to ensure managerial oversight. The properQMR process allows management to fulfil their regulatory obligations, while simultaneously creating a platform for feedback, regulatory & audit transparency, and process improvement.
Banking & Financial Services
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Medical Devices
https://laegemiddelstyrelsen.dk/en/devices/new-regulations/
Reinforced supervision and control of medical devices
The regulations tighten the rules for testing medical devices on patients to ensure the availability of documentary evidence of device testing. In addition, manufacturers of medical devices must meet stricter requirements as regards following up on the quality, performance and safety of devices.
The rules are also tightened for notified bodies and for the authorities’ monitoring of notified bodies. Notified bodies are responsible for assessing medical devices in medium- and high-risk classes before medical devices can be marketed in the EU. The new regulations also give the notified bodies a right and a duty to carry out unannounced on-site inspections at the manufacturer. Further information on the different risk classes is available here.
Energy & Utilities
Government Agencies
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Automotive