Service
Customized report evaluating the regulatory requirements (e.g. MDR/IVDR/FDA) and tests needed according to the applicable standards.
- Medtech
- Consulting
- Biotech and Lifescience
Director, Regulatory and Clinical Development
Alira Health
Barcelona, Spain
13:30 - 14:00
Service
Customized report evaluating the regulatory requirements (e.g. MDR/IVDR/FDA) and tests needed according to the applicable standards.
Service
Critical differences between the current state of device's development and where you would like to be.
Service
Report identifying and assessing important regulatory issues of an asset.
Service
Product Classification and Categorization
Determine main Mode of Action and product categorization in EU and/or US market(s).
Service
Clinical Development Plan, Study design, Synopsis and Protocol preparation.
Service
Country – Specific Requirements
Support manufacturers in Switzerland, UK, Canada, APAC, LATAM and other regions
Service
GTM Strategies encompassing Regulatory, Clinical and Commercial requirements.
Service
Customized training services including specific on-site trainings.
Service
Functional Service Provision: outsourced Regulatory team as part of client’s cross-functional team.