June 7, 2019

Cross Cultural Business Communication: Holding Hands

Many years ago, I found myself in a foreign city at a conference, spending a few minutes on my company’s booth, when all over sudden a man walks up, grabs my hand, leads me to a display on our booth and starts asking questions about my company and our products. All the while, for the

May 28, 2019

Compliance with ISO 14155 serves the safety of patients during clinical trials

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

April 30, 2019

EU MDR Implementation: A Presentation To OCRA, Orange County Regulatory Affairs Discussion Group (Part 3 Of 3)

Presentation to OCRA – March 13th, 2019 – on EU MDR Implementation, at the Allergan Auditorium (Part 3)   Economic Operators   Most Medical Device companies understand the issues surrounding notified bodies. They have been well documented and are often discussed at MDR events. But I’d like to draw your attention to the multiple economic

April 3, 2019

EU MDR Implementation: a Presentation to OCRA, Orange County Regulatory Affairs discussion group (Part 2 of 3)

Presentation to OCRA – March 13th, 2019 – on EU MDR Implementation, at the Allergan Auditorium (Part 2) Costs associated with MDR implementation   Most of you have thoroughly read through the MDD and the MDR? In comparison the MDD is a small document. A mere 23 articles and 13 annexes. The MDR is a

March 14, 2019

EU MDR Implementation: a Presentation to OCRA, Orange County Regulatory Affairs discussion group (Part 1 of 3)

Presentation to OCRA – March 13th, 2019 – on EU MDR Implementation, at the Allergan Auditorium (Part 1) From MDD to MDR Over the past few years manufacturers paid a lot of attention to the new European Medical Devices Regulations and the challenges and opportunities created by the changeover from the Medical Device Directives to

January 29, 2019

4 mistakes to avoid when entering the US market.

Many foreign companies are interested in offering their products for sale in the HUGE US market. Besides, the market is relatively uniform. Seemingly one language and one culture make it easier to localize a global product to the US market than localizing it for the 28 different countries of the EU for instance. But many

October 4, 2018

The Southern California Life Sciences Clusters

Life Sciences Clusters Overview:   The Southern California Life Sciences Clusters are created by bringing together world-class academic institutions (UCLA, USC, Caltech, UCSD, UCI,), top-notch research facilities (Scripps Research Institute), a close-knit medical community and Human and financial capital.   1,796 medical device and equipment manufacturing firms, and 1,453 biotechnology and pharmaceutical companies in California

August 13, 2018

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,

June 22, 2018

MedTech Manufacturers, EU Distribution: Importer and Distributor Agreements (Part 2).

With the new MDR’s coming closer it becomes urgent for companies present in the EU market to sort all matter of distribution issues. The EU distinguishes several levels of economic actors: the Manufacturer, the Authorized Representative, the Importer and the Distributor, and each of these actors is now referred to in the Regulations. In this

June 18, 2018

MedTech Manufacturers, EU Distribution: Authorized Representative Agreements (Part 1).

With the new MDR’s coming closer it becomes urgent for companies present on the EU market to sort all matter of distribution issues. The EU distinguishes several levels of Economic Operators: Manufacturer, Authorized Representative (AR), Importer and Distributor. In this first article we will review the role of the Authorized Representative.   The Authorized Representative