medtech

When we last left off at Spreadsheet Validation (part 1), we had covered the various standard and regulatory requirements that apply to spreadsheet validation and the types of spreadsheets that require validation. Now, as promised, part 2. Spreadsheet Validation under ISO 13485 Starting with determining criticality classification, we will also examine the relationship that exists […]

Michelle Keane discusses CAPA in Medical Devices including potential reasons organizations struggle and the FDA raise so many findings in this area.

As per ISO 13485, is it true or false that a medical device organization that uses spreadsheets is only required to validate spreadsheets that contain calculations?

Comply Guru proudly sponsored Global Access 2024 which is ‘s largest conference for Quality and Regulatory Affairs Professionals in Medical Devices.