State of the Art: Recommendations for writing a thorough SOA and build SOA Libraries for your CERs
About this Event

Date: Sep 2, 2024

Time: 1 PM EST

Duration: 90 Mins.

Level: Intermediate to Advanced

Group Packages: Please contact [email protected]

Description

This webinar will showcase the importance of State of the Art in Clinical Evaluation Reports for Medical Devices and provide tools and recommendations for writing a well-structured SOA setting the stage for the entire CER. The webinar will also provide recommendations to build a State-of-the-Art Library for your medical device portfolio.

Why Should You Attend:

Both, the European MDR and MEDDEV 2.7.1 rev 4 requires that the risk/benefit analysis for any medical device be assessed considering the current state of the art and that the person performing the clinical evaluation of any clinical data be knowledgeable about the state of the art.

Notified bodies are issuing formal citations for non-conformities in clinical evaluation reports of medical devices, specifically pertaining to the state-of-the-art analysis.

SOAs, if not written with their main intent in mind, often fail to provide context for whether the subject device in the CER addresses a significant gap in managing the medical condition. The SOAs also fail to demonstrate whether the subject device has an improved or at least equivalent benefit/risk profile compared to existing devices or therapies.

This webinar will help you prevent these failures, teach you how to efficiently prepare before writing an SOA and show you how to best write and present your clinical data in each section of the SOA. Additionally, recommendations will be provided to build your own SOA Library to meet CER update timelines for your products portfolio.

Areas Covered in the Webinar:

What is State of the Art (SOA)?
How does the SOA establish the context of the CER?
Recommended process and tools to write a thorough SOA
Where do we find the content to write an SOA?
Recommended Literature search Strategy
How to write the different sub-Sections of an SOA
Recommended tools to summarize and present SOA clinical data
What are the pitfalls of SOA writing?
How to build an SOA library for your products portfolio

Who Will Benefit:

Clinical Affairs Personnel
Regulatory Affairs Personnel
Medical Directors / Safety Officers
Medical literature search librarians/services
CER medical writers and technical writers

Speaker: Maria Sanchez, Founder and President, Medical Device Safety Group Inc

Maria Sanchez is the founder and President of Medical Device Safety Group, Inc., a consulting company providing quality services for medical device manufacturers.

Ms. Sanchez has more than 10 years’ experience in complaint handling processes, post-market safety surveillance, risk management, and Clinical Evaluation Reports in medical device companies.

Ms. Sanchez holds a Master in Business Administration (MBA) and a Bachelor’s in Science of Nursing (BSN). Additionally, she is a Certified Quality Auditor (CQA) and Manager of Quality/Organizational Excellence from the American Society for Quality (ASQ).

Additional service: (Personalized session)

We also do various similar customized events for our clients and it is specially tailored as per the client's requirement. We arrange calls between clients and our course instructors to better understand the training requirement and accordingly a training program is designed. The course duration ranges between 90 Mins and 12 hours. Most 6 hours and 12 hours of classes are split into 2 to 3 days considering customer convenience.

We have 500+ consultants who are associated with us and each have their own specialization example GxP, GMP,GLP, 21 CFR, Computer system validation, FDA Audit & Inspection, Bioassays, Design Control, Data Integrity, FDA regulation, Clinical compliance, and almost everything that falls under Risk, Quality and Compliance arena in the Life Science industry.

If you think that your team needs some kind of boost, update or refresher in Risk management and Regulatory compliance then let me know and we can design a highly cost efficient program for you.