Beruflich Dokumente
Kultur Dokumente
Johnathon Bis
VP Medical Devices Solutions Sales
BSI Group America
10 Clause
Structure
• Many additions
• Increased clarity of
interrelationship between clauses
and requirements
Scope & Role Organizations provide Medical Organizations can be involved in one or more
devices and related services stages of the life-cycle including the design
and development, production, storage and
distribution, installation, or servicing of a
medical device and the design and
development or provision of associated
activities (e.g. technical support). This
International Standard can also be used by
suppliers or external parties that provide
product including quality management
system-related services to such organizations.
Regulatory Improved
Requirements
linkage of
clauses
Will continue to accept ISO 13485: 2003 & 2016 Only MDSAP
CMDCAS
Accept both ISO 13485 and MDSAP
• e-Updates
• Webinars & Recordings
• White Papers
• Frequently Asked Questions
• Training
bsigroup.com/ISO13485
revision