DAVID O’CAEIRO

That will Boost Your Company’s compliance productivity. Working in a team can be a communication challenge, from rallying people around a project, chatting constantly, losing attachments in chat, sending a bunch of emails and trying to keep everyone on the same page, to organizing and disseminating information is a tough job. More than that - compliance becomes a...

  So you want to design a new version of your medical device? Here’s what you need to do to ensure ISO and FDA compliance. As a medical device design engineer, you know every part of your design; you know how all the pieces fit together and how they are built and their purpose. Sadly, it also...

In today’s modern world there is no space for time-wasting. The challenge of time was best expressed by William Penn when he said, “Time is what we want most, but what we use worst”.  Managing time in a fast-growing business world requires serious sets of skills   The new generation of Document Management Software offers various solutions on a...

It’s official, workplace emails are an ineffective tool for managing projects. Don’t confuse Emailing a link to your team as collaboration - that’s ping-pong! And sending your team an email and asking them to either comment or provide input on a file, an idea, a suggestion is like trying to push a wet string. Although email...

In a global environment, companies are facing countless complex, unique industry challenges. Quality becomes not just a buzzword but a true competitive advantage – companies that deliver the best quality products and services efficiently - succeed.     ISO certification, (be it ISO9001, ISO13485…)  communicates a commitment to quality to both customers and regulators. There are many benefits...

Elements of effective team collaboration & best practices Establishing and developing a productive and successful team can be tricky. Have your team ever struggled to collaborate successfully in real-time or online? Nowadays, working together remotely is a necessity for most teams and companies. We have to get used to using online collaboration tools. These tools allow...

ISO’s standards are created to guide companies in dealing with some of the most demanding challenges of modern business – Quality & Customers. At its core, the ISO system is underpinned by the pursuit of recognizable quality that ties business goals and customer needs. The aim is to make business operations as efficient as possible...

ISO 12651-2 defines a document as "recorded information or object which can be treated as a unit". Err… Yup!... Got it!... Been treating recorded objects as a unit for, well… forever…   Sometimes you just have to admire their creativity! Compliance requests essentials On the more serious side, we’re still talking compliance and for that, there are 6...

“Individuals play the game, but teams win championships” Bill Parcells As in sport, the same rules apply to business. Collaboration is the glue that binds teams. Collaboration is different people executing together on the same issues, cooperatively whether communicating through Chat, Voice, Video or email. But when the business involves regulatory and ISO compliance, the collaboration also...

When digging deeper into a part where ISO 13485:2016 defines roles,  we can get a headache of how to define QMS management. It might be tricky to come to define Is it a job or is it a role in an organization? A QMS manager is a one-person Job with a very critical role, so we...

Software as an industry is unique in that not only can it be a product it can also be a service. Moreover, it is its own means of production;  Increasingly software can be found in all kinds of products, products that are ever more built to ISO standards, a.k.a. quality standards. And where quality and ISO...

What is a role and how does it connect to processes?   The 2016 edition is much more complicated than the 2003 edition so here is a little help to make things a little more understandable. In ISO 13485:2016 there are many new terms, definitions, and requirements compared with the 2003 edition. "First, a stab of the ISO bureaucrats…...

Your email address is the proverbial key to the internet. No email address, no account at Facebook, no streaming, no whitepapers, no downloads. Whether you use Gmail, Yahoo, AOL or a host of others, you need an email account because it’s your ID on the web; after all, “You’ve Got Mail”. If you don’t need an...