Making clinical research crystal clear
Krystelis Medical Device Services
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Krystelis offers comprehensive medical device consulting services to support pharmaceutical and medical device companies navigate complex regulatory environments. Our expert team provides end-to-end assistance, ensuring compliance with global regulations, from product conception through post-market surveillance.
Our Services
Regulatory Compliance
- Registration of Establishment
- Premarket Notification 510(k) and Premarket Approval (PMA)
- Investigational Device Exemption (IDE)
- Medical Device Reporting (MDR)
- Quality System (QS) regulation
- ISO 13485 certification support
- Customised regulatory strategies for FDA approval
- Preparation of technical files, device master files, design dossiers, and design history files
- Clinical evaluation plan
- Informed consent
- Investigator’s brochure
- Clinical evaluation reports
- Literature search for real-world evidence collection
- Evidence summaries
- Instruction for use of the device
- Periodic safety update report
- Technical document
- Summary of safety and clinical performance
- Post-approval changes management
- Labeling requirements compliance
- Import and manufacturing licenses
- Registration of innovative/new medical devices
- Complaints management
Advantages of Using Krystelis
Medical Device Services
Regulatory Expertise
In-depth knowledge of global regulations ensures compliance with EMA, FDA, and other authorities.
Comprehensive Services
End-to-end support from product conception through post-market surveillance.
Customised Strategies
Tailored regulatory strategies to meet specific customer and product needs.
Experienced Team
A skilled team with a proven track record in device registration and navigating regulatory pathways.
Quality Assurance
Commitment to maintaining high-quality standards and patient safety through robust quality systems and certifications.
