Business Analysis

IS YOUR ROLE BUSINESS ANALYSIS?

As a Business Analyst, you are critical in choosing the right labeling solution. You are in a unique position of researching, understanding and recommending the overarch infrastructure of the required solution, along with its challenges and opportunities.

It is your responsibility to convey these findings to key stakeholders.

We provide not only a configurable labeling solution that enables you to meet all the requirements of the project, but we also have our internal experts ready to discuss any specific needs. Our in-house teams can support you with validation and compliance through project planning, risk assessment, testing implementations and supply full documentation.

“We knew what level of quality we required and the PRISYM system not only delivered, but exceeded our expectations. Unlike PRISYM, many of the other systems we considered did not provide the correct level of service and security, which is an especially important factor in our industry. Plus, the PRISYM ID’s labeling software is user-friendly and has a very useful reminder mechanism.”

CHOSEN BY THESE CUSTOMERS...

OFFERING THESE PRODUCTS AND SERVICES...

PRISYM 360

This solution provides organizations with complete label integrity to meet the strictest compliance requirements for FDA & EU regulations, specifically FDA 21 CFR Parts 11, 810, and 820.

Read More

PRISYM SaaS

This solution enables organizations to address the challenges of complying with FDA and other regulations by delivering access to a compliance ready platform in the Cloud.

Read More

SERVICES

Our team of in-house compliance and validation subject matter experts and professional services and support teams can support you from implementation through beyond delivery.

Read More

BUSINESS ANALYSIS LABELING RESOURCES

EU MDR EU MDR’s Impact on Labeling: UDI in Europe and Other Changes Posted in: Achieving Regulatory Compliance, Business Analysis, Increasing Operational Efficiency, Medical Device, Operations & Labeling, Project Managers, Reducing Risks, Regulatory & Compliance, Supply Chain, Webinar -

Join medical device labeling and data experts from PRISYM ID and Reed Tech to learn about what the EU Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) mean for labels in this free webinar.

Read More
EU MDR infographic - EU MDR – Is the Industry Planning for It? Are You? EU MDR – Is the Industry Planning for It? Are You? Posted in: Achieving Regulatory Compliance, Business Analysis, Infographic, Information Technology, Medical Device, Operations & Labeling, Project Managers, Regulatory & Compliance, Supply Chain -

Whether you’re producing medical devices within Europe or supplying to Europe from the rest of the world, as a manufacturer or supplier, you will need to adhere to the EU MDR by May 2020.

Read More