Label Compliance Challenges for Small and Medium Sized Medical Device Companies
Can the cloud help?
When it comes to medical device labeling and traceability, the smallest companies have the same obligations and requirements as companies many times larger, but have to meet them with few resources and within the tightest of budgets. The size of the organization does not matter — the FDA and other regulatory bodies do not draw distinctions.
Many small and medium sized companies (SMEs) in this sector have met these labeling challenges in innovative ways that work for them at the moment... The problem is this invariably involves manual record keeping, multiple physical copies of labels to prove change control and will inevitably consumes large amounts of time. Time you don’t have.
You will also hear from an SME in this industry, Global Quality Systems International (GQSI) that has already adopted SaaS for management of their clean room and non-sterile UDI medical device packaging, labeling and re-labeling service. By the end of the webinar you will be able to make an informed decision on whether pursuing a SaaS solution will work for you.
Key Learning Objectives:
- How building and maintaining compliant labels in the cloud can be cost effective
- How using this type of technology will save you valuable time
- How you will reduce risk of product recalls resulting from labeling errors
- How this approach addresses security, reliability and performance concerns
MEET OUR SPEAKERS
Chris Lentz - VP SaaS Business Development, PRISYM ID
With over 25 years’ experience in enterprise software solutions across many sectors, Chris has spent the last several years implementing and bringing to market SaaS offerings that enable organizations to access high quality services based on leading software technologies.
Working closely with a Life Sciences focused cloud provider and PRISYM ID’s test and validation experts to deliver a compliance ready solution for small to medium sized companies in the Medical Device sector, Chris manages the SaaS operations team and maintains relationships with customers to ensure on-going feedback and development.
Will Graham - President, Global Quality Systems International
Will has over 25 years in Process and Quality Systems Design, Development and Implementation in regulated industries including Medical Device, Chemical, Pharmaceutical, Automotive and Aerospace. With specialist expertise and certification in quality management Will is fully versed in the challenges facing medical device manufacturers.