Reports Regulatory Compliance

Reports and Regulatory Compliance

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Medical devices are some of the most highly regulated products in the world, and necessarily so, but it can be confusing and time consuming to prepare all the necessary documents for your project.

Munro Medical has over 20 years of experience dealing with regulatory bodies in the United States and in Europe. Additionally, we are developing an expertise for Japan. Munro Medical can prepare protocols for:

  • Clinical literature searches
  • Clinical trials
  • Inspection
  • Testing

We can write clinical literature reviews, clinical evaluation reports (CER), 510(k) submissions, and other documents for the FDA, Notified Bodies in the EU, and for Japan. We can interpret your testing results and provide an unbiased opinion on them for your dossier.

We are well versed on MedDev 2.7/1 version 4 as well as the new Medical Devices Regulation (MDR), which will go into effect in 2020.

 

Articles

 

How to Prepare for the EU’s New 2020 Medical Device Regulation

Link to How to Prepare for the EU’s New 2020 Medical Device Regulation, 6-page PDF

Big changes are underway for the European market and how it regulates medical devices with the recent unveiling of the Medical Device Regulation MDR 2017/745. This regulation replaces the longstanding Medical Devices Directive (MDD) 93/42/EEC, specifically MedDev 2.7/1 for medical devices, which was created in 1992 and most recently updated to Revision 4 in July 2016.

 

Challenges to International Device Reimbursement

Link to Medical Device and Diagnostic Industry online article: Challenges to International Device Reimbursement
As the world grows smaller, national politics increasingly affect global healthcare economics. Although the medical device industry has boosted its international harmonization efforts, wide variation still exists with respect to healthcare reimbursement. Therefore, device companies must understand reimbursement schemes in their relevant geographic markets before making any significant investment in product development.

The goal of this article is to provide foundational knowledge for U.S. device companies for selecting markets in which product reimbursement will most likely be secured. It also aims to help OEMs craft a unified approach to international product marketing that addresses differing national requirements, particularly in Canada and within the European Union (EU).

 

Convergence, Collaboration, Commercialization

Link to Medical Device and Diagnostic Industry online article: Convergence, Collaboration, Commercialization
Technology convergence and corporate collaboration are propelling rapid changes in today’s medical device industry. Technology convergence is emerging from often disparate disciplines in order to address a wide array of clinical disorders that biologics, devices, or pharmaceuticals cannot resolve independently.

Meanwhile, corporate partnerships are enabling manufacturers to collaborate on such common goals while maximizing the strengths and minimizing the weaknesses of each partner. Partnering across the biotechnology, medical device, and pharmaceutical fields represents an excellent method of creating better, smarter products, and achieving mutual growth.

 

Start With the Problem: The Entrepreneurial Approach to Engineering

Link to 52-page PDF: BONEZONE, Volume 16, Issue 3, August 2017. Link will open on page 45: Start With the Problem: The Entrepreneurial Approach to Engineering
We’ve all been there—the boss, the sales rep, the customer, or someone from another department rushes in with a problem they need solved stat. They tell you what they want you to do and ask how soon you can get it done. The temptation to just implement their idea into a fully-fledged solution is enormous. And why not? It gets the job done, makes them happy, and lets you move on to other problems that need solving. I’ve succumbed to this kind of thinking many times, and the results are always the same—an adequate design that leaves me and everyone else feeling flat. This article presents ideas on how to produce your best work. Link to publication online: BONEZONEpub.com, August 2017.

 

White Papers

 

Clinical Literature Reviews: Changes in the European Union’s Medical Device Directive Require Manufacturers to Take Immediate Steps to Comply

Link to 9-page PDF: Clinical Literature Reviews: Changes in the European Union’s Medical Device Directive Require Manufacturers to Take Immediate Steps to Comply
This white paper, written in 2008, advises that manufacturers, now faced with an enormous amount of work to complete in a short period of time (2010 deadline), take immediate steps to deal with the coming changes. At stake is maintaining or increasing share in the growing $86 billion market that accounts for a significant percentage of most U.S. medical device companies’ profits. With nearly 8,000 devices on the EU market, it is possible that a backlog of applications as the deadline approaches could bottleneck approvals, with serious implications for sales and profits.

 

The Power of Meta-Analysis: How Smart Companies are Using a Statistical Methodology to Drive Breakthroughs

Link to 7-page PDF: The Power of Meta-Analysis: How Smart Companies are Using a Statistical Methodology to Drive Breakthroughs
Often, businesses find that they cannot perform a clinical study with enough patients to provide statistical significance to the results, so they must combine their results with those of others to determine safety and efficacy. Other businesses feel their products are far superior to others currently on the market, but to gain market share, they need to demonstrate the benefits of their products across a large cross-section of the population. Whatever the reason, meta-analyses are powerful tools that the medical device industry can use to promote and gain approval for innovative new products.

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