Our Experties

Looking in to the complex and competitive global medical device landscape, Regulatory approval of medical devices requires convincing clinical evidence. The accuracy of the data gathered is critical to the success of a medical device clinical study. Here lies Valnizen’s forte/expertise of offering you high-quality, dependable clinical trial data required for regulatory approval of your device. Our clinical trial team will collaborate closely with you to ensure you that the clinical investigation plan accurately represents you to Ethics Committees (EC) and complies with Good Clinical Practice (GCP) guidelines as well as the local regulations.

Valnizen ensures adherence to Good Clinical Practices (GCP), the European Clinical Trial Regulation (No 536/2014), the MDR/IVDR, and ISO 14155:2020 – Clinical Investigation of Medical Devices for Human Subjects, as well as ISO 20916:2019 – In-vitro Diagnostic Medical Devices. – Clinical performance studies using human subject specimens – Good research practice MDT can be involved in all or part of your clinical investigation operations, depending on your budget and the availability of in-house specialists.

Services Offered:

Project Management

• Clinical Strategy.
• Study design and protocol development.
• Clinical document creation and management.
• Ethics Committee and Competent Authority Submission in the EU.

Clinical Monitoring

• Clinical Investigation monitoring
• Clinical Investigation Post market study design and management.

Data management

• Paper or EDC data collection capability.
• Clinical database development, entry, processing, querying, maintenance, and reporting

Bio-Statistics and Medical writing

• Technical Documentation and Report.
• Creation of study progress reports.

Whether your product is a medical device, biologic, or drug, careful consideration of regulatory requirements is key. Each milestone must be planned with your business strategy, development timeline, and regulatory pathway in mind. And, every challenge must be managed strategically. Your entire development process could depend on it. To make your compliance efforts impactful in this stringent and sophisticated medical device industry ecosystem, choosing a right regulatory partner is always essential. A skilled regulatory consulting firm can assist you in your effort to meet all regulatory requirements, whether your objective is to develop the rationale for the equivalence of your medical device, confirm your regulatory pathway and your clinical evaluation strategy, or prepare for and obtain market approvals. We are expert in the field providing regulatory consultation and services for device manufacturers and innovators/start ups looking to introduce their products in Global market.

Services Offered:

Medical Devices

• International/Local Medical device regulatory consultation
• MedTech Roadmap: From patent to the market (EU MDR/FDA).
• Regulatory Strategy (CE Mark, IDEs, 510(k)s, De Novo, PMA, HDE Strategy
• Technical File Development and Compilation for Class I, II, and III.
• UDI consulting.
• ISO 14971 risk management consulting for medical device companies.
• Post Market Clinical Follow Up (PMCF).

In Vitro Diagnostic

• International/Local In Vitro Diagnostic regulatory consultation
• IVD Roadmap: From patent to the market (EU IVDR/FDA).
• Technical File Development and Compilation for Class A, B, C, and D Devices.
• UDI consulting.
• ISO 14971 risk management consulting for in-vitro diagnostics companies.
• Post Market Performance Follow Up (PMPF).