GET A DEMO

FDA Provides Wellness Device Testing Guidelines. What's Your Next Move?

[fa icon="calendar'] Sep 7, 2016 3:25:07 PM / by Pat Flanders posted in Quality & Compliance, Medical Devices, FDA

[fa icon="comment"] 0 Comments


Last month, the US Food and Drug Administration (FDA) released a document that provides guidelines and compliance information for companies that manufacture wellness devices. As opposed to devices that are invasive or provide extensive screening or testing capabilities, wellness devices are in a category the FDA considers "low risk", and outlines the classification within the document.

Read More [fa icon="long-arrow-right"]

Too Late for a QMS: Theranos' Ignoring FDA Compliance Will Cost it Billions

[fa icon="calendar'] Sep 1, 2016 3:46:59 PM / by Pat Flanders posted in Quality & Compliance, Audit, Certification

[fa icon="comment"] 0 Comments

Theranos, the once-hot clinical testing start-up, has taken a beating in the press recently. With almost $700 million in venture funding and buttressed by promises of dramatically new and better ways of testing blood samples, the company was once poised to be a model for life sciences companies of the future. Agile and smart, Theranos rapidly moved into a huge market on the back of its proposed innovative solutions.

"...given the amount of scrutiny they're under, I would have expected them to be particularly careful about the regulatory issues surrounding research on human subjects."

Read More [fa icon="long-arrow-right"]

Case Study: How Qualio helped eHealth Technologies achieve SOC 2 Type II Certification

[fa icon="calendar'] Aug 16, 2016 1:34:12 PM / by Anoop Aulakh posted in Case Studies, Digital Health, Audit, SOC2 Type II

[fa icon="comment"] 0 Comments

eHealth Technologies’ success revolves around its ability to securely and responsibly handle sensitive patient information. Each time a contract is signed with a new customer, a thorough due diligence process takes place, which includes a security assessment verifying up to 300 items.

 In 2015, the company sought to streamline this time consuming process as its business expanded. To do so, eHealth Technologies required an external security audit to achieve Service Organization Control No. 2 (SOC 2) Type ll Certification. This certification could be presented to customers in lieu of the lengthy security questionnaire, and the credentials would help establish trust in addition to reducing the time and cost of due diligence.

Read More [fa icon="long-arrow-right"]

Life Sciences Conferences for Quality Managers to Attend

[fa icon="calendar'] May 27, 2016 5:08:48 PM / by Anoop Aulakh posted in Quality & Compliance

[fa icon="comment"] 0 Comments

When you work in quality management, it's important to keep up with the latest in compliance and regulation requirements. Conferences can a great way to update your knowledge and expand your network at the same time. Since there are so many events throughout the year, it's also important to invest your time wisely.We spoke to a few of our customers recently to learn which events they found valuable. Here is a roundup of upcoming conferences to consider checking out:

Read More [fa icon="long-arrow-right"]

How to Rock ISO 13485, Cardiaccs Did It 2x Faster with Qualio

[fa icon="calendar'] Apr 27, 2016 8:50:41 AM / by Damien Barry posted in Case Studies

[fa icon="comment"] 0 Comments

Cardiaccs AS was founded in 2009 as a result of 8 years of research and development by the Intervention Centre at Oslo University Hospital in cooperation with Buskerud and Vestfold University College. In 2014, the company received funding from the Research Council of Norway/FORNY2020 program to commercialize their Cardisense sensor technology.

Read More [fa icon="long-arrow-right"]

We’re changing our name from ZenDoc to Qualio

[fa icon="calendar'] Oct 31, 2015 11:51:58 AM / by Robert posted in Updates

[fa icon="comment"] 5 Comments

We’ve got some big news. On November 6th ZenDoc will officially become Qualio. We’re changing our name to more accurately reflect our company vision. The past two years have been incredible and now it's time to double down on our efforts to become the simplest way for businesses to manage quality & compliance. The first step on this path is a rebrand to reflect our new focus. The important thing to know for now is that when the switchover happens all links to ZenDoc will now take you to Qualio and everything will work just as it did before. That means you can expect the same great service as always, now under a new name.

This change coincides with the opening our first office in the United States. Now with locations in San Francisco, CA and Dublin, Ireland we can better serve our customers all over the world.

Best regards,

Robert & the team at Qualio

P.S. Have any questions about this change?

Let us know in the comments!

Read More [fa icon="long-arrow-right"]

If it’s not documented, it didn’t happen

[fa icon="calendar'] Nov 18, 2014 7:33:30 AM / by Nancy Watts posted in Quality & Compliance

[fa icon="comment"] 0 Comments

Read More [fa icon="long-arrow-right"]

Qualio is the Digital/Online Startup of the Year

[fa icon="calendar'] Oct 30, 2014 4:03:56 AM / by Robert posted in Updates

[fa icon="comment"] 0 Comments

Dana accepting the award from Gavin Duffy (Judge) and Maeve Dorman (PayPal)

Read More [fa icon="long-arrow-right"]

Taking Qualio Quality Management Software from a concept to reality

[fa icon="calendar'] Jun 23, 2014 12:45:53 AM / by Robert posted in Updates

[fa icon="comment"] 0 Comments

Qualio launched in April after a spending months in a closed beta with over 70 companies. This was the result of 2 years of hard work, 1000's of customer interviews and many product iterations. And after all this we've built something we can all be proud of. To everyone that provided feedback and support during this time; Thank you, we couldn't have done it without you.

Read More [fa icon="long-arrow-right"]

This Will Save Us Years – Lean LaunchPad for Life Sciences

[fa icon="calendar'] May 6, 2014 2:06:15 AM / by Robert posted in Business

[fa icon="comment"] 0 Comments

Part 1 of this post described the issues in the drug discovery.  Part 2 covered medical devices and digital health. Part 3  described what we’re going to do about it. This is post is a brief snapshot of our progress. Vitruvian is one of the 28 teams in the class. The team members are:
Read More [fa icon="long-arrow-right"]