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Compliance & Regulatory

How PLM Enables Innovation Without Risking Compliance

How PLM Enables Innovation Without Risking Compliance

As technology has advanced, it's become more complex -- and with complexity comes the issue of tracking and monitoring the different processes and their corresponding data. In non-critical applications, the extent of this reporting is often minimal. However, in...

PLM: Automate your Product Development Compliance Process

PLM: Automate your Product Development Compliance Process

Developing new and innovative products is essential for companies to survive and thrive -- however safety can never take a backseat to innovation. That is why many companies, like those in the Medical Devices, Aeronautics and Automotive industries, have strict...

The FDA UDI Rule: 5 Things You Need to Know

The FDA UDI Rule: 5 Things You Need to Know

The release of the FDA final rule on Unique Device Identification (UDI) is expected this summer. Here are five things you need to know: 1. What is the UDI Rule? In July 2012, the FDA proposed a rule requiring medical device manufacturers to label their products with...

Tackling Email Archiving Regulations

Tackling Email Archiving Regulations

Whether or not your in a heavily regulated industry, having a solid email archiving solution is an absolute necessity. Email’s importance in the workplace for the past decade-and-a-half is similar to the need of having a dial tone in years past. In addition, email is...

Risk Management in the PTC Integrity Medical Device Solution

Risk Management in the PTC Integrity Medical Device Solution

An important part of creating any product intended for use in the medical field is that the manufacturer should have identified all of the risks involved in using the device, and have done their best to mitigate those risks before their product ever sees a patient....

Security and Compliance – What Your Company Needs to Know Part 2: MBSA

Security and Compliance – What Your Company Needs to Know Part 2: MBSA

You need more than just an antivirus and security suite to keep your system safe. You need multiple, non-redundant solutions covering various aspects of network security. In our last blog, we discussed the role of whitelisting in keeping your network secure. Now we’re...