Medical Device Pre-launch

Ensuring the safety, integrity, and effectiveness of medical devices requires strict control over their storage, handling, and transport. Medical devices are sensitive to environmental conditions such as temperature, humidity, and mechanical stress, which can compromise their functionality and sterility. Compliance with international regulatory standards, including ISO 13485, ISO 14971, EU MDR, and FDA guidelines, is essential to mitigate risks associated with storage and distribution. Through proper validation of these processes, manufacturers and suppliers can prevent product degradation, avoid regulatory penalties, and ensure patient safety. This blog explores the importance of storage, handling, and transport validation, key regulatory requirements, and best practices for ensuring compliance.

Cleaning validation is a critical process for ensuring the safety and effectiveness of medical devices by verifying that they are free from harmful contaminants such as biological residues, chemical remnants, and particulate matter. This process is essential for meeting stringent regulatory standards, including ISO 13485, ISO 14971, EU MDR, and FDA guidelines, which mandate thorough cleaning protocols to mitigate risks to patients and device functionality. By defining acceptance criteria, conducting risk assessments, and performing robust validation testing, manufacturers can establish consistent cleaning processes that meet compliance requirements.

Medical Device labelling is a key requirement of regulations world wide. Manufacturers of medical devices are required to ensure that the products they place on the market are appropriately labelled, this enables traceability, and key information to users on how to use the devices safely.

Notified Bodies are essential for ensuring product safety and compliance. Whether your business operates in the European Union (EU) or the United Kingdom (UK), understanding how to work with these organizations is vital. This blog explains the role of Notified Bodies, their importance under EU and UK regulations, and what manufacturers need to know.