Regulatory: MedTech

Strategy and Roadmap Development

Delivering sound strategies and executable roadmaps

The Alira Health takes a holistic view in creating your regulatory strategy and plan. Our regulatory experts, doctors, scientists, and strategists work together to deliver tailored solutions that meet both regulatory requirements and your business objectives.

A focus on efficiency

Our strategies are designed to help you balance risk, increase speed, and decrease costs associated with:
  • Aligning regulatory strategy with client marketing claims, indications for use and business objectives
  • Orphan designations
  • Breakthrough designations
  • Fast track designations
  • Adaptive design programs
  • Direct-to-patient programs
  • Hybrid programs
  • PRIME programs

Why choose Alira Health?

As your partner, Alira Health supports your innovation, optimizing product development success every step of the way. Our integrated, collaborative teams provide a lifecycle approach to delivering our services, including:

  • Regulatory strategy
  • Regulatory intelligence
  • Regulatory operations
  • Clinical
  • Market access

Related news

Publications February 2, 2023
Outlook 2023: Firms Prepare For ‘World Where Health Care Has No Limits’
In the latest publication by Medtech Insights by Pharma Intelligence, executives at top device companies and other stakeholders share their expectations.
MedTech Pharma
News January 31, 2023
The Playbook for Patient Engagement in MedTech in the U.S. is Launched
The MedTech Patient Engagement Think Tank announced today the launch of the Playbook for Patient Engagement in MedTech in the U.S.
MedTech Patient Engagement
Publications January 31, 2023
A Playbook for Patient Engagement in MedTech in the U.S.
“A Playbook for Patient Engagement in MedTech in the U.S.” is a result of amalgamating ideas, research, findings, and forecasts from industry subject matter experts that together(...)
MedTech Patient Engagement
Publications January 19, 2023
Medical Device Regulation in 2023: A Window of Opportunity
We spoke with our team of regulatory experts about the recent news regarding the MDR and the opportunity it presents to device manufacturers in 2023.
Medical Devices MedTech Regulatory
Publications January 19, 2023
What’s Next for Diabetes: Patient Engagement, Personalization, and Usable Technology
Alira Health partnered with the ADA to support this conversation and explore the most important topics emerging from patients, physicians, specialists, and patient advocates including(...)
Clinical Trials Diabetes MedTech Patient Engagement
Publications January 17, 2023
Insights on the MedTech Industry
In 2023, the MedTech industry will seek to turn the challenges of disruption into opportunities for lasting transformation. Discover the three keys that a successful MedTech company(...)
Healthcare Technology MedTech Patient Engagement
Events January 11, 2023
MD&M West 2023
Join our colleague Carlo Stimamiglio for his presentation “MedTech CDMO: Market and M&A Trends in 2023”, as he goes over key takeaways from our upcoming 2023 US MedTech CDMO Report.
CDMO MedTech
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