RESOURCES
The CRO Group offers the following resources to help with regulatory changes.
We have Seminars to help you get ready for MDSAP, MDR/IVDR, and other topics. Check out our FREE PREVIEWS:
Preparing for MDSAP Preview
Help Prepare Your
Company for MDSAP!
EU MDR and IVDR Update
What Changes Under EU MDR and IVDR?
This Seminar Preview Informs You.
EU MDR and IVDR Update preview
Navigating FDA and EU SaMD Requirements
All the Regulatory and QMS
Requirements for your SaMD
Coming Soon!
Preparing for MDSAP 培训 准备
帮助您的公司准备
MDSAP审核
IEC/ISO 62304 for SaMD Preview
Need to set up your SDLC for SaMD
to meet IEC/ISO 62304 requirements.
This Seminar Preview explains how.
ISO 62304 for SaMD Preview
Navigating FDA and EU Wearable/OTC Requirements
All the clinical, regulatory and QMS
Requirements for your OTC/Wearable
Coming Soon!
Risk Management per ISO 14971
Setting Up Risk Management per
Standards, Regulations, Guidances, etc.
Getting Ready for ISO 13485:2016
What you need to know and do
to get ready for the ISO 13485:2016 audit
Get started with this Preview
Getting Ready for EN ISO 13485-2016 preview
如何准备ISO 13485:2016认证
13485:2016 合规培训
2016新版：变更重点和合规建议
ISO 13485-2016 Mandarin preview
Our FDA Warning Letter Previews cover many inspection issues, and are available to our Subscribers.
FDA Warning Letter Preview
FDA Warning Ltr #1 Preview
Inadequate Supplier Controls,
Risk Analysis, Design Verification
FDA Warning Letter Preview
FDA Warning Ltr #2 Preview
Inadequate Software Design
Controls amid Changes
FDA Warning Letter Preview
Warning Ltr #3 Preview
21 CFR Part 11 Electronic
Signature/Document Controls