This session will greatly help you streamline your 510(k) preparation and submission process at your firm for maximum benefits in a least burdensome, effective manner.
David will share his PASS-IT solutions based on what he has learned from his own experience including his recent analysis of various different types of 510(k)s that have been recently cleared.
This session is a must for regulatory professionals working in medical device industry including those who are interested in the topic.
Areas Covered in the Session :
Statute(s) and regulations
Definitions
Device classification and how to identify predicates: key factors
510(k) program: when the requirement is of 510(K)
Regulatory requirements
510(k): requirements, contents and format
Substantial equivalence: special considerations
The task of addressing e-Copy and RTA policy requirements
Some of the common mistakes for RTA policy requirements
Applicable standards and guidance
Common pitfalls and how to prevent them: dos and don’ts
What to ensure while preparing for a 510(k) application
Response to FDA’s request of additional information
Resolving some of the different opinions and interpretations: dos and don’ts
Speaker’s practical, actionable and sustainable solutions (PASS)
Best Practices to achieve compliance and to stay compliant: dos and don’ts
PASS-IT suggestions and recommendations
Who Will Benefit:
Medical device quality and compliance professionals
Pharmaceutical compliance professionals
Quality
Regulatory affairs
CEOs
VPs
Attorneys
Clinical affairs
Research & Development
Consultants
Contractors/subcontractors
Anyone interested in the 510(K) matters
Price Tags:
Live
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
For more information and enquiries contact us at
Compliance Trainings
5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458
Email : support@compliancetrainings.com
David will share his PASS-IT solutions based on what he has learned from his own experience including his recent analysis of various different types of 510(k)s that have been recently cleared.
This session is a must for regulatory professionals working in medical device industry including those who are interested in the topic.
Areas Covered in the Session :
Statute(s) and regulations
Definitions
Device classification and how to identify predicates: key factors
510(k) program: when the requirement is of 510(K)
Regulatory requirements
510(k): requirements, contents and format
Substantial equivalence: special considerations
The task of addressing e-Copy and RTA policy requirements
Some of the common mistakes for RTA policy requirements
Applicable standards and guidance
Common pitfalls and how to prevent them: dos and don’ts
What to ensure while preparing for a 510(k) application
Response to FDA’s request of additional information
Resolving some of the different opinions and interpretations: dos and don’ts
Speaker’s practical, actionable and sustainable solutions (PASS)
Best Practices to achieve compliance and to stay compliant: dos and don’ts
PASS-IT suggestions and recommendations
Who Will Benefit:
Medical device quality and compliance professionals
Pharmaceutical compliance professionals
Quality
Regulatory affairs
CEOs
VPs
Attorneys
Clinical affairs
Research & Development
Consultants
Contractors/subcontractors
Anyone interested in the 510(K) matters
Price Tags:
Live
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
For more information and enquiries contact us at
Compliance Trainings
5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458
Email : support@compliancetrainings.com
