House of MDR manages projects of any scale on your behalf. Projects may also relate to food supplements, cosmetic products or pharmaceuticals. Our experts assist in product risk management projects to achieve full ISO 14971 and MDR compliance.
Are you familiar with risk management requirements laid down in MDR and ISO 14971? We are.
Risk Management is one of the most important element in MDR and without it, there is no chance to survive. Why? Because it ensures patient safety, meets strict regulatory requirements, and protects patient health by systematically identifying, evaluating, and controlling risks throughout a device’s entire lifecycle. It goes beyond mere compliance by building long-term trust and preventing costly issues like recalls and legal action.
House of MDR offers comprehensive risk management services according to EU MDR and ISO 14971, including
House of MDR offers project management services lifecycle from an initial idea to the end, encompassing all key phases of medical devices. Our experts has long practical experience and industry backgrounds and understand the regulatory, technical and commercial challenges. We ensure your medical device is of the highest quality and meets regulatory requirements.
