Biomedical Division Northern California Discussion Group andSan Francisco Bay Area Chapter Topic: “Evolving Risk-Based Regulatory Requirements” whole day workshop covering 3 key quality & regulatory areas: IEC 60601-1, 3rd ed. general, collateral, and particular standards including essential performance, risk management integration,
Med Dvcs E-Lableing: Health Canada TPD’s Interpretation
On November 9, 2010 Health Canada’s Therapeutic Product Directorate (TPD) issued an interpretation of the Medical Devices Regulations (Regulations) with respect to electronic labeling (e-labeling) of certain medical devices sold or imported into Canada. This interpretation only covers products for
EU Interpretative Doc on Placing Med Dev’s on Mrkt
On 16 November 2010 this Interpretative Document was issued to explain what is considered Placing Medical Devices on the EU Market. The document refers to all 3 medical device directives including the amendment 2007/47/EC. The 3 medical device directives this
IEC 80001-1 1st ed Application of Risk Mgmt for IT Networks Incorporating Med Dvcs
IEC 80001-1 edition 1 was published Oct 27, 2010 and is for the “Application of risk management for IT-networks incorporating medical devices – Part 1: Roles, responsibilities and activities” The scope states, noting that all ALL CAPITAL words are defined
FDA Modifications to List of Recognized Standards, List 025
On Oct 4, 2010 the Federal Register published the “Modifications to the List of Recognized Standards, Recognition List Number: 025“. This list will assist medical device manufacturers who elect to declare conformity with FDA Consensus Standards to meet certain FDA