Begin with the end in mind
You need to think ahead and ask the right questions to uncover potential regulatory risks that could set you back.
Are my preclinical studies addressing biocompatibility endpoints?
Do my predicates align with reimbursement and regulatory goals?
What are the regulatory compliance requirements of my targeted global marketplace?
Efficiently integrating your market approach from conception to completion ultimately saves you time, money and effort. By looking at product classification, required quality standards and required testing upfront, you can avoid unnecessary testing and facilitate discussions with regulators and notified bodies to prepare for regulatory submissions.
Our regulatory specialists start early, examining every aspect of regulatory compliance to identify potential issues that could impact your design, materials, manufacturing methods or financial plans. Leveraging worldwide experience with regulatory agencies, we cultivate novel, targeted strategies to help you achieve regulatory approval in your target markets.
Comprehensive regulatory consulting capabilities:
- Regulatory Strategy
- Project Management
- Device Claims Development
- Design Control Support
- Risk Management Support
- Biological Safety Evaluation
- Regulatory Submissions
- Regulatory Compliance Consulting
- Audit Preparation & Support
- Regulatory Interface Support
- Registration & Licensing Support
- Clinical Evaluation Reports (CERs)
- Post-Market Clinical Follow-up Plan Support
Changes to EU Clinical Trial Regulation No.536/2014