Empire HealthTech
Name
*
First Name
Last Name
Email
*
example@example.com
Phone Number
Please enter a valid phone number.
Format: (000) 000-0000.
What is your device/portfolio family?
*
Is your device...
*
CE-marked and seeking to sustain CE-mark
Not CE-marked and seeking to earn CE-marking
Not CE-marked and NOT seeking to earn CE-marking
What type of content are you looking for help with?
*
Regulatory Documentation (Clinical Evaluations, Post-Market Surveillance, Technical File)
Communications (Whitepapers, Conference Material)
Regulatory Document Types
Clinical Evaluation (CEP, CER)
Post-Market Clinical Follow-Up (PMCF Plan, Report)
Post-Market Surveillance (PMS Plan, PMSR, PSUR)
Summary of Safety and Clinical Performance (SSCP)
Instructions for Use (IFU)
Technical File/Documentation
Risk File
Communication Deliverable Types
Whitepaper
Publication
Website Copy
Blogs/Newsletters
Press Briefs/News Articles
Conference Decks
KOL Education Decks
Is the update you're seeking to outsource due to an audit response/deficiency?
*
Yes, FDA
Yes, Notified Body
Yes, internal
No, compliance update
When are you looking to have your deliverables completed?
*
Do you have SOPs in place you'd prefer we follow?
*
Yes
No
We have SOPs but would like input/review
Submit
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