Makromed Costa Rica, in association with MyFDA Academy, invites you to register for our Medical Device courses.

• Earn a certificate as you complete each course.
• Become an expert on Software Validation and Cybersecurity.
• Get certified as a PV SME when you complete all the Process Validation courses.
• Get ready for 510(k) and new eSTAR process.

Available courses

• Get certified as a PV SME if you take all five of the PV courses:
  • Process Validation Overview / $250 / 7-Mar-2024
  • Sampling Plans for PV and TMV / $250 / 21-Mar-2024
  • Equipment Qualification (EQ/IQ) / $250 / 4-Apr-2024
  • Test Method Validation (TMV) / $250 / 25-Apr-2024
  • Operation and Performance Qualification (OQ/PQ) / $250 / 9-May-2024
• Software Validation / $350 / 23-May-2024
• Cybersecurity for Medical Devices / $250 / 6-Jun-2024
• 510(k) Submissions / $250 / 20-Jun-2024
• Statistical Methods for Medical Devices / $250 / 11-Jul-2024

Training for all courses listed above will be conducted at Venture X, Segundo piso, City Mall, Alajuela, Costa Rica.

TO REGISTER: If paying by credit card, use this form to select and pay for the courses you would like to take. If paying by other methods, please download/save this form, complete it, and e-mail it to us.

Presented by the Makromed team having extensive experience and international reputation in offering QMS consulting services and QMS software to address the compliance requirements of: U.S. FDA's GMP / QSR, EU's MDD / MDR, ISO 13485, and other global regulations and standards.

Learn about Makromed, Inc. and its experience
Makromed, Inc. is an ISO 13485 certified U.S. based company that has 13 years of presence in Costa Rica and 30 years internationally. We are staffed with highly qualified professionals in various disciplines, focused on the Pharmaceutical and Medical Device industry, both in Costa Rica and worldwide.

Solutions we provide
We are known for providing innovative software and consulting solutions for quality and regulatory compliance to the medical device, pharmaceutical, nutraceutical, and biotechnological industries worldwide.

Visit Makromed
Visit MyFDA Academy

Let us be part of your solution, implementing our know-how and best practices developed over the years.

Learn more about our professional speakers
Barry Ashar
Christian Castro