Yearly Archives: 2017
Being a Great Team Member
October 30, 2017 Leadership Development, Project Management/Leadership There are multitudes of articles and books that contain advice on how to be a great leader. But what if you’re like most of us and not at the top of the food chain? In most teams, there is one leader and a team of people doing the work. While we like to place the responsibility for a project’s success or failure on the leader, every team member has ownership and influence on how a project turns out. Your contribution to the project must…
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MEDDEV 2.7.1 Rev 4, and what it means to you
If you manufacture a medical device that is CE marked, you are required to comply with the latest MEDDEV 2.7.1 publication. This revision is a major rewrite from the previous publication of Rev 3 as the authors sought to bring clarity and layout stricter expectations for Clinical Evaluation Reports (CERs). Compliance expectations ultimately fall on the manufacturer, and the Notified Bodies are being given greater responsibility in enforcement as they perform audits. Rev 4 is 50% larger than its predecessor because of the level of detail. Fortunately, the document was…
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Where to Start With Medical Device Compliance Changes
Begin with the End in Mind: This is the second habit Steven Covey lays out in his famous book, The Seven Habits of Highly Effective Sales Leaders. The reason this habit is so important is that it aligns all tasks, projects, and talent toward a single purpose. This habit also provides a framework to eliminate tasks and projects that will not help accomplish the end goal. With major regulatory shifts occurring in the medical device industry it is imperative that device manufacturers know exactly which “end” to keep in mind.…
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MDSAP – The Beginning of a 3 Year Debacle For Medical Device Companies
The Notified Bodies are already very busy and our medical device manufacturing clients are already seeing increased audit times. Several European Notified Bodies are no longer taking new clients with the onset of MDSAP (inclusive of ISO13485:2016), MEDDEV 2.7.1 Rev. 4 & MDR. This is the beginning of a 3-year debacle for medical device companies. These substantial regulatory reforms are now underway and will be required over the next 3-5 years: MDSAP will become the mandatory replacement for the CMDCAS certification to support Canadian device approvals on January 1, 2019…
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How to Execute your Medical Device Regulation (MDR) Plan
The stakes seem high and the risk is real, but in a very large sense executing your MDR project is just another project. This is the fifth blog post in a serious on the changing European regulations in Europe. The previous four discussed what MDR is and why it is a concern, how to prioritize your devices in preparation for the new regulations, what to be thinking about as you perform a gap analysis, and finally, how to build a plan. Phases of Project Management A normal development project will…
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Creating a Plan of Action for Medical Device Regulation (MDR):
This is the fourth blog post in a series on the changing European regulations in Europe. The previous three outlined what MDR is and why it is a concern, how to prioritize your devices in prep for the new regulations, and what to be thinking about as you perform a gap analysis. Building A Plan of Action This blog post concentrates on how to build a plan of action. If you need a refresher, please see the other posts or reach out to us and we can discuss how these…
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How to Perform a Medical Device Regulation (MDR) Gap Analysis
When you sit down to address your gap analysis between MDD and MDR, there are a host of questions you will want to think about. This list is not expected to be comprehensive but it should be a good place to start. What changes are needing to be for your devices? You need to begin by comparing what the changes are for your device: what is new or different under MDR that you did not have to comply with under MDD. Once this is compiled, you should consider the regulatory…
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Prioritizing Your Medical Devices for MDD to MDR conversion
When you are creating a priority list for your Class II and III Medical Devices, you need to take many things into consideration. Most people look for the simple answer: How much revenue and profit is generated in Europe by my list of products? This can be a good litmus test, and might even be the right one for you. But we encourage you to take a step back and look at the bigger picture. You should ask yourself what the impact is of each of your products going off…
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Introduction to European Medical Device Regulation (MDR)
The European Union (EU) is set to shift the regulatory structure of medical devices from MDD to MDR compliance. Simply put, Class II, Class III, and other high-risk medical devices are going to require recertification under a new set of rules to remain on the market. The EU will not allow any devices to be grandfathered in. When your existing certification ends, you will be required to make sure you are in compliance. If this is not taken care of, your products may go off the market in Europe. If your…
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Micromanaging: Neither Good nor Evil
To micromanage or not to micromanage: that is not the question. Rather you should ask yourself how each member of your project needs to be managed. And to answer that question, you need to be very aware of the strengths, weaknesses, and personalities of each member of your team. Engaging with members of your team Some people need constant attention and are only effective when they are micromanaged. They need the daily check-in with the positive (or negative) reinforcement that comes with that. Their ability to focus requires they feel…
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