Regulatory Strategies & Advice for MedTech Start-up Companies

RAC Credits
Tuesday, 20 June 2023 (9:00 AM) - Tuesday, 20 June 2023 (5:00 PM) Eastern Time (US & Canada)
5635 Fishers Ln
Rockville, Maryland, USA, 20852-1796

Start-up companies within the MedTech industry often focus on innovative product development and short timelines for bringing medical devices to market, frequently not factoring in regulatory requirements upfront. However, understanding regulatory affairs and the regulatory approval process is an essential component for success and staying within budget.

This workshop will provide a fundamental overview of regulatory requirements in Europe and the U.S. However, the focus will be regulatory strategies that might suit companies and acquiring regulatory knowledge.


March 1, 2023 — May 20, 2023: Early Bird $665 Member | $785 Nonmember

May 21, 2023 — June 20, 2023: Regular $785 Member | $920 Nonmember

Registration fee includes:

  • Breakfast and lunch
  • Continuous beverage break service
  • Wi-Fi
  • Parking

Learning Objectives:

  • Understand essential regulatory requirements for medical devices in Europe and the U.S.
  • Differentiate regulatory strategies for start-up companies.
  • Regulatory advice and support for startups.

Audience Learning Level:

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.

Who Should Attend?

Regulatory professionals, especially those at startups and managers of start-up companies.


Jennifer Neff

Jennifer Neff
DVM, PhD, MBA, RAC, Chair

Dr. Jennifer Neff has worked in the areas of medical devices, pharmaceuticals, and biotechnology for more than 16 years and recently joined the Bitop AG as head of medical devices & principal consultant regulatory, clinical affairs & QM. Previously, she held regulatory affairs and clinical affairs positions at Sartorius Stedim Biotech, Bess AG, Bayer Health Care, Parexel Consulting, Berlin Heart, and Biotronik. Her experiences include a broad range of medical devices, such as tracheobronchial stents, ventricular assist devices, tumor markers, and substance-based. Prior to joining the industry, Neff was a practicing veterinarian. She is chair of the European Council of RAPS and board member of the RAPS’ German Chapter.

Susana De Azevedo Waesch

Susana De Azevedo Waesch
Vice President of quality management and regulatory affairs

Susana de Azevedo Wäsch is vice president of quality management and regulatory affairs with Ypsomed AG. She has more than 25 years of experience in medical devices, pharmaceuticals, and biotechnology. Wäsch is experienced in the areas of regenerative medicine, implants, drug-device combination products and infusion pumps. Prior to Ypsomed, she worked at Geistlich Pharma AG, Switzerland; Eidgenössische Technische Hochschule Zürich; Lonza Visp, Switzerland; the European Bioinformatics Institute, Cambridge, England; and the U.S. Center for Advanced Research in Biotechnology. She is also a director of the RAPS EU Board.


5635 Fishers Lane
Terrace Level
Rockville, MD 20852


Parking will be free at RAPS HQ with a validated ticket. Please make sure to bring your parking ticket to registration to validate parking. Overnight parking is not allowed.

Local Hotels:  

Hilton Washington DC/Rockville Hotel & Executive Meeting Ctr 
1750 Rockville Pike 
Rockville, Maryland, 20852-1699, USA 
Telephone: (301) 468-1100 
Hotel Website 
Distance to RAPS HQ: .8 miles 
Directions to RAPS HQ 


EVEN Hotel Rockville  
1775 Rockville Pike 
Rockville, MD 20852 
Telephone: (301) 881-3836 
Hotel Website 
Distance to RAPS HQ: .7 miles 
Directions to RAPS HQ 

Be Well Policy

RAPS has initiated a Be Well policy, with consent required during the registration process. This includes the stipulation that if you feel sick or are experiencing COVID-like symptoms prior to traveling or while onsite at RAPS HQ, you will reconsider your participation at the event. 

To ensure your personal safety and comfort during this event, RAPS is committed to robust and transparent communications during the event. We encourage all participants to monitor RAPS social media channels and download the conference app to their mobile devices to receive up-to-the-minute updates.

Cancellations and Refunds

All cancellation requests must be submitted in writing to Cancellation requests received by 6 June 2023 will receive a full refund minus a 20% administrative fee. Cancellation requests received after 6 June 2023 will be non-refundable, except in cases of documented medical emergencies. RAPS is unable to accept cancellations by phone. Refunds will not be issued for no-shows.


Paid substitution requests received, and approved in writing by RAPS before the start of the event, will be honored. To transfer a registration, email with the event title, original registrant’s name, and substitute’s contact information.

Meeting Cancellation

RAPS reserves the right to cancel any program at its sole discretion, whereupon all registration fees will be refunded within seven business days. RAPS is not responsible for any costs incurred due to a cancellation. 

Photography Policy

By registering for this RAPS Event, you grant full permission to RAPS to capture, store, use, and/or reproduce your image or likeness, photograph, voice, and comments, and use such content in any and all media or forms by RAPS or third parties without compensation or notice, including for promotional or advertising purposes. You also waive any right to royalties or other compensation arising from or related to the use of the images, recordings, or materials. By registering, you release, defend, indemnify and hold harmless RAPS from and against any claims, damages or liability arising from or related to the use of the images, recordings or materials, including but not limited to claims of defamation, invasion of privacy, or rights of publicity or copyright infringement, or any misuse, distortion, blurring, alteration, optical illusion or use in composite form that may occur or be produced in taking, processing, reduction or production of the finished product, its publication or distribution. 


Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email

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