Meet Danielle Giroud, convener of the ISO expert group on clinical investigations, at the OCRA Orange County Regulatory Affairs Discussion Group, June 19th event on ISO:14155:2019 Register: https://lnkd.in/enqdjCd Medical devices may only be placed on the market if their performance and safety have been clinically evaluated. The harmonized standard ISO 14155:2019 “Clinical testing of medical Read More …
Tag: Medical Devices
Exporting an Unapproved Investigational Device from the US in Support of a Clinical Trial in a Foreign Country.
Over the past few weeks I’ve had several conversations with manufacturers and consultants alike regarding the export of an Unapproved Investigational Device for use in a Clinical investigation to be conducted entirely outside the United States. One of the first comments I get asked: does the FDA have jurisdiction? While the answer is easy, Read More …
Skip Domestic. Commercialize in a Foreign Market first?
Over he last few months, several companies that had not commercialized their products in their domestic markets asked me about entering one or another foreign market. Normally, I tell them that’s probably not a good idea. The reasons behind my statement are straightforward. Entering a foreign market is more difficult than addressing your Read More …
Should US MedTech companies be concerned about the new EU Medical Device Regulations?
The EU market has always been attractive for US MedTech companies. Obtaining approval to sell into the EU market has in the past always been easier than getting approval to sell in the US. That may soon change in view of the new EU Medical Device Regulations. For a long time, US manufacturers preferred to Read More …
Assess and Protect against Product Liability Claims when Entering a Foreign Market
When you enter a Foreign Market you will probably face a Product Liability regime different than the one in your home country (Similar But Still Separate and Distinct). Chances are your company is not intimately familiar with the risks in the market you plan to enter. Our experience has shown that “the unknown” can often Read More …
Hurdles facing European MedTech companies wanting to enter the US Medical Device market.
Last week I visited the Medica show in Dusseldorf, Germany, the world’s biggest medical devices trade fair. 120,000 professional visitors from over 130 different countries met with more than 5,000 companies. I spend four days meeting with European MedTech companies that didn’t have a presence in the US market. I wanted to know why they Read More …
Invest in a Strategic International Business Development Plan. Consider Regulatory Restrictions
As your company contemplates expanding its market into foreign countries, sometimes regulatory restrictions play an important role. Think about a company selling supplements, or mechanical components for the aerospace industry. In such an environment, investing in a Strategic International Business Development Plan may mean the difference between certain failure and success. Regulatory Restrictions It may very well Read More …