Making clinical research crystal clear
Krystelis Medical Device Services
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
Regulatory Strategy Development
- Customised regulatory strategies for FDA approval
- Preparation of technical files, device master files, design dossiers, and design history files
Medical Writing for Devices
- 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
- Summary of safety and clinical performance
- Technical document
Post-Marketing Support
- Post-approval changes management
- Labeling requirements compliance
- Import and manufacturing licenses
- Registration of innovative/new medical devices
- Complaints management
Advantages of Using Our 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.