Medical device regulations are becoming increasingly difficult. We can help you comply with local, regional, and global regulatory requirements affecting your products. All major regulations have their own specific requirements, although there are harmonized essential requirements that are valid in each country. We have extensive experience in U.S. FDA, EUMDR, EUIVDR, CFDA, TGA, Health Canada, and other major global regulations.
We assist our customers in summary technical documentation (STED) files, Clinical Evaluation Report (CER), Performance Evaluation Report (PER), Design Dossiers, 510(k), PMA, UDI, Remediation, CAPA Management, Gap Identification, Recommendation, and Implementation for DHF/Tech Files. We have extensive experience in Pathology, Chemistry and Immunodiagnostics, Transfusion Medicine, Cardiology, Orthopaedics, Spine, ENT, RPM, Trauma, Extremities, Radiology, and many more segments. We will get your products to market quickly and assist in maintaining your compliance status.
JCIPL’s experts will ensure you achieve your goals on time. We will be there when you need someone to assist you to answer questions from the regulatory body. To build or stay in compliance you will have to create or update technical documentation. A Notified Body or a regulatory body will review your technical documentation and verify if it complies with the medical device regulations for geography. JCIPL helps you to prepare technical documentation, technical files, and design files.
1. MDR/IVDR Tech Files Services
2. CER and PER Services
1. MDR/IVDR Tech Files Services
Our regulatory expert’s team works with you to make documentation ready for your product in Europe.
- Summary technical documentation (STED) files as per EU IVDR (2017/746) and EU MDR (2017/745), Manufacturer’s Incident Reports (MIR), and field safety actions and notices, and device-specific vigilance reporting per MEDDEV 2.12-1 rev. 8
- Notified Body selection
- Labeling and Instructions for Use
- Medical Device Reporting and Vigilance Reporting
- Manage compliance strategy and risks
- Develop and sustain a competitive advantage
- Protect your brand
- Our consultants can temporarily be an extension of your team to manage regulatory compliance issues
- Minimize business impacts such as loss of sales, product recall, and obsolete inventory
- Support reporting incidents and field actions
- Summary of Post Market Surveillance
2. CER and PER Services
We have strong expertise in writing clinical evaluation reports for all classes of medical devices. Our clinical experts have extensive experience in clinical writings on a variety of medical devices including Orthopaedics, spine, radiology, cardiology, and surgical instruments.
- Clinical Evaluation Reports and Literature Reviews per MEDDEV 2.7.1 revision
- MAUDE search and analysis
- State of art development
- IVDR Gap Assessment
- Risk and benefit analysis
- Expertise in PubMed, Embase, Google Scholar, and other popular databases
- Performance Evaluation Report (PER) Article 56 of the IVDR with focus on all three elements: scientific validity, analytical performance, and clinical performance
- Extensive experience in various segments including Pathology, Chemistry and Immunodiagnostics, Transfusion Medicine
- Technical writing of clinical documents like Analytical Performance reports, Clinical Performance reports, and Scientific Validity reports
