Certifications

Certifications

ISO 13485 Certificate is an important Certification required by the manufacturers, designers, suppliers, distributors, and service providers of all medical devices including in vitro devices (IVDs). The regulatory body involved in the process is the Accredited Notified Body.

offers a variety of mock audits to help you ensure regulatory readiness. Assess a wide range of regulatory requirements to identify areas of risk and perform due diligence activities, or rely on NSF to support your internal and supplier audit programs.

Provides complete range of audit for assessment Our regulatory specialist and experienced team from industry will provide full support & guidance, at all levels.

Bio-State Consulting Pvt. Ltd. provides end to end consulting services for Medical Devices and IVDs.

Bio-State Consulting Pvt. Ltd. is preferred regulatory consulting partner for all scale of companies seeking to introduce innovative, safe and effective products.