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
Author
Alira Health
About
Regulatory, Quality, and Compliance
Regulatory Compliance and ConsultingQuality Assurance and Testing in MedTechNotified Body Services
Digital Health and Advanced IT
Artificial Intelligence in Healthcare
Clinical Research and Diagnostics
Clinical Research and Trials
Manufacturing and Product Innovation
Wearable Medical Devices and IoTImplantable and Surgical DevicesTherapeutic and Rehabilitation DevicesConsummable and Disposable DevicesBiomaterials and Tissue EngineeringEmergency and Critical Care Equipment
Market Access and Business Development
Pharma and Drug-Device Combination DevelopmentHealth Economics and Market AccessStartup and Innovation Incubators in Healthcare
Policy, Advocacy, and Education
Public Health Policy and Government AffairsMedical Education and Training Programs
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Marketplace (17)
Service
Report identifying and assessing important regulatory issues of an asset.
- Consulting
AuthorService
Critical differences between the current state of device's development and where you would like to be.
AuthorService
Product Classification and Categorization
Determine main Mode of Action and product categorization in EU and/or US market(s).
- Consulting
AuthorService
Clinical Development Plan, Study design, Synopsis and Protocol preparation.
- Consulting
AuthorService
EU Technical Documentation Preparation
Preparation and/or review of the Technical Documentation or any specific section that forms part of the Technical Documentation.
AuthorService
EU Notified Body (NB) and National Authorities
Support and accompaniment during the evaluation and interactions with regulatory authorities
AuthorService
Internal audit capacities as per MDR/IVDR, and per ISO13485:2016, QMSR, and MDSAP
Author- Author
Service
FDA Submissions including Documentation Preparation
Advise, prepare and manage FDA package submission
AuthorService
Quality Management System Gap Analysis
Quality Management System analysis and recommendation on how to solve the gaps
AuthorService
Quality Management System Implementation
Materials and Support for the implementation of a Quality Management System
Author- Author
Service
Country – Specific Requirements
Support manufacturers in Switzerland, UK, Canada, APAC, LATAM and other regions
- Consulting
AuthorService
GTM Strategies encompassing Regulatory, Clinical and Commercial requirements.
- Consulting
AuthorService
Customized training services including specific on-site trainings.
- Coaching
- Consulting
AuthorService
Functional Service Provision: outsourced Regulatory team as part of client’s cross-functional team.
- Consulting
- Development
Author