Implementation of ISO 13485 MasterClass

Implementation of ISO 13485 MasterClass shall describe the general increase in combination products and in particular products now regulated by both drug and medical device regulation it is important to decide if, when and how ISO13485 should be implemented within your organisation.

Key Elements:

• Medical device quality system requirements and when they apply to medicinal products.
• Determining whether to implement ISO13485 in the design of drug.
• How ISO13485 helps the design transfer for the drug delivery device.
• How ISO13485 is similar and different to standard drug GMP.
• Understand the correlation between ISO13485, international regulations and ISO14971
• Pharmacovigilance V medical device vigilance.

Visit the official website to learn more about the MasterClass