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A Medical Device Technical Manager is a professional appointed by a medical device manufacturer or distributor to assume specific responsibilities related to product compliance and quality management. This role is especially relevant in the context of the European Medical Device Regulation (MDR) and the European In Vitro Diagnostic Medical Device Regulation (IVDR), where manufacturers, importers and distributors are required to appoint a person with technical competence and adequate experience to perform these functions.
Typical responsibilities of a Medical Device Technical Manager may include:
Ensure compliance: The Technical Manager is responsible for ensuring that medical devices manufactured by the company comply with all applicable regulatory and regulatory requirements.
Quality system management: The Technical Manager may be responsible for the management and maintenance of the company's quality management system, ensuring that established quality standards are met.
Risk Assessment: Participate in the risk assessment of medical devices to identify and manage potential risks associated with their use.
Technical Documentation: Prepare and maintain technical documentation required to support product conformity, including test reports, risk assessment results, and other relevant documents.
Change Tracking: Manage and control changes to medical devices and manufacturing processes, ensuring they are made appropriately and product conformity is maintained.
Collaboration with regulatory authorities: Interact with regulatory authorities and notified bodies on behalf of the company on issues related to product conformity and quality management.
Training necessary to be a Technical Manager for medical devices
The European Medical Device Regulation (MDR) and the European In Vitro Diagnostic Medical Device Regulation (IVDR), like the AEMPS, establish general requirements for the technical competence of the Technical Manager.
These regulations establish that the Technical Manager must have the appropriate training, experience and technical knowledge to perform responsibilities related to product conformity and quality system management. This means that the training required may vary depending on the complexity and risk associated with the medical devices being manufactured, imported or distributed.
Some areas of training and experience that may be relevant for a Technical Manager include:
Education in biomedical engineering, health sciences or other related fields.
In-depth knowledge of applicable medical device legislation and regulations, including the MDR, IVDR and other relevant regulations.
Relevant work experience in the medical device industry, including design, development, manufacturing, quality control and risk management.
Familiarity with international quality and safety standards, such as ISO 13485 (Quality Management Systems for Medical Devices) and ISO 14971 (Risk Management for Medical Devices).
Effective communication skills and leadership ability to work with multidisciplinary teams and coordinate activities related to product compliance and quality management.
It is important that the Technical Manager is constantly updated on changes in regulations and advances in the field of medical devices, and that he demonstrates a continuous commitment to quality and patient safety.
In summary, the Medical Device Technical Manager plays a crucial role in ensuring that medical devices manufactured or distributed by a company meet regulatory and regulatory requirements, as well as in the effective management of the company's quality system. This role requires a high level of technical competence and experience in the medical device field.
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