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Our regulatory experts have more than 10 years of experience in medical devices, combination products, and tissue engineering. We possess the scientific background and regulatory expertise necessary to handle all European and North American requirements and to successfully organize and conduct your clinical studies — getting you through the red tape quickly and smoothly. Our extensive global network of contacts with notified bodies, competent authorities, and trade associations is your key to saving time and money.
Premier Research develops worldwide regulatory strategies and solutions to meet your practical needs, including:
- CE Mark Process
- Conformity assessment
- Notified body selection and ongoing contacts
- Development of risk assessments
- Strategy development
- Pre-clinical strategy development and support
- Preparation of expert assessment
- Liaison with notified bodies and competent authorities
- Design of quaility systems (ISO 13485)
- Design dossiers and technical documents
- 510K
- PMA
- IDE
- Field safety notice and field safety corrective actions
- Recall process
- Classification and strategy
- Data requirements
- Authority contacts
- Marketing/national strategies and advice
- Preparation of submissions
For more information on our Medial Device group and service offerings, please contact us.
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