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REGULATORY AFFAIRS
AltaQ has successfully completed regulatory submissions for IVD, LDT, and Medical Device companies.
We can help as part of your team to design and execute studies to achieve regulatory submission target milestones.
PMA
Pre-Market Approvals (PMAs) for IVD and medical devices
510(k)
Traditional, Abbreviated, and Special 510(k)
NYS - CLEP
New York State - Clinical Laboratory Evaluation Program
EU MDR
Medical Device Regulations (MDR) for medical devices - CE Mark
International
PMDA (Japan), NMPA (China), TGA (Australia), etc.
De Novo 510(k)
De Novo 510(k) for IVDs and medical devices
IDE
Investigational Device Exemptions (IDEs)
Pre-Submissions
FDA pre-submissions (Q-subs) for IVD and medical devices
EU-IVDR
In-vitro Diagnostics Regulations (IVDR) for CE Mark
30 years
Our team members have been serving the life science industry for more than 30 years.
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