Loading ...
My Account
|
[0] |
CONTACT US
The Leaders in Quality and Regulatory
Training & Consulting
Need Assistance?
1.800.472.6477
Home
About Us
Our People
Who We Serve
Office Locations
Our Name
Employment
how we work
Consulting & Auditing
Quality System Audits for ISO 13485, FDA QSR, MDSAP
Preassessment & FDA Mock Audits
Internal Audits - ISO 13485, FDA QSR, MDSAP
Auditor Training
Supplier Audits
Performance-Based Auditing
Remote Medical Device Audits
Connected Medical Devices, SaMD & IoMT
ISO 27001 ISMS & Cybersecurity
Software Validation and Verification
FDA 21 CFR Part 11 Compliance
Medical Device RA/QA
Medical Device RA/QA Training
QMS Implementation
Medical Device QMS Auditing
ISO 13485:2016
MDSAP Auditing
ISO 14971 / Risk Management
CAPA Process Consulting
Medical Device CE Certification
EU MDR (2017/745)
EU MDR Gap Assessment
EU Clinical Evaluation Reports (CER)
EU IVDR (2017/746) Consulting
Nonproduct Software Validation
US FDA PMA Preparation
US FDA 510(k) Submissions
FDA Q-Submission
FDA IDE Submissions
Emergency Use Authorizations (EUA)
US FDA 483 Mitigation
RA/QA Outsourcing
ISO 9000 & Related Standards
Management System Documentation & Implementation
ISO 13485
ISO 9001
ISO 27001
Performance Excellence
Lean Six Sigma
Design for Six Sigma DMADV
Find a Training Course
All Courses
Medical Device RA/QA
Virtual Instructor-Led Classes
ISO 9000 & Related Standards
Performance Excellence
Private Team Training
Certificación Costa Rica
Resources
White Papers and Market Updates
Case Studies
Blog
Customer Log-In
Returning Customer
If you already have an account, please sign in below.
E-mail*:
Password*:
Forgot your password?
New Customer
Create an account to place an order or to view your orders and training history.
Request More Info
Share This Page
Subscribe to Newsletter
Request a Proposal
Or ask a question!
Get answers right now. Call
1.800.472.6477