October 10-11, 2018 there is a two-day, Amsterdam 510k workshop for medical devices at the Doubletree by Hilton Amsterdam Centraal Station.
October 10, 2018 Agenda
October 11, 2018 Agenda
The Amsterdam 510k Workshop will focus on FDA requirements, 510k submissions and preparing for your product launch in the USA. The workshop has room for 40, but we expect less than 25 people. Registration for the workshop is a total of $600 for both days. There is no discount available for attending only one day. The agenda for each day is provided below.
A networking lunch is included registration fee for each day, and all attendees will receive electronic copies of the speaker presentations, an electronic copy of the book “How to Prepare Your 510k in 100 Days,” and a complete set of electronic 510k document templates. More important than what you receive, is what you will learn.
Register for Amsterdam 510k workshop on October 10-11, 2018
We can also invoice you if you for the Amsterdam 510k workshop prefer or provide a receipt invoice for tax purposes. Just send an email to: firstname.lastname@example.org. We also accept payments via PayPal, Squareup and Zelle the same email address.
You can ONLY get the 510k book by attending Medical Device Academy’s Amsterdam 510k workshop or by purchasing the on-line 510k course.
Oosterdoksstraat 4, Amsterdam, 1011 DK, Netherlands
Call for Directions & Reservations: +31-20-5300800
Click on the picture to the right in order to get reduced hotel rates when you register.
Speaker biographies for the Amsterdam 510k workshop
Rob Packard is a regulatory consultant with ~25 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone 802.281.4381 or email. You can also follow him on Google+, LinkedIn or Twitter.
Mary is a biomedical engineer and consultant with Medical Device Academy. She graduated from Wichita State University and has experience in Q/A and BioMed. Mary has experience with 510k submissions for reprocessed single-use devices, sterile devices, electrical devices and standalone software. She also has experience with CE Marking and Canadian Licensing application. She served both as an engineer and the Head of Quality Assurance at Biomedical Devices of Kansas. As a guest speaker, Mary is going to explain how design controls and risk management should be integrated with the process of your 510k preparation.
Mary Vater – Consultant for Medical Device Academy