At BAI we do In-depth analysis to identify and address gaps in your processes, ensuring a robust foundation for compliance. Through review of client-specific technical documentation we ensure we meet mandatory standards and enhance your document integrity.
BAI helps organization with conformity to assessment procedures.
• Review & understanding of Company information and device specific technical information like Intended Use, Device description, Model & Variant details,device classification critical suppliers, QMS etc.,
• Gap Analysis
• Establishing Technical Documentation as per applicable Regulations like Device Technical Files, Clinical Evaluation Reports, Risk Assessement, Usability, PMS, PMCF etc
• Design and develop QMS processes and procedures aligned with the organization's business objectives and compliance requirements.
• Develop and deliver awareness programs for employees.
• Provide specialized training for QARA/PRRC individuals responsible for implementing controls.
• Promote a culture of quality within the organization.
• Provide support during implementation of QMS controls and measures to address identified risks.
• Handhold wherever required
• Internal implementation reviews and readiness
• End-to-end support right from selection till the achievement of Certification.
• Trainings, Audits & technical guidance
• Regular risk assessments, audits, and updates to QMS processes and procedures
• Technical guidance on Registering Devices in specific markets like India, EU, US.
We are passionate about our work and how it translates into Return on Investment for our valued partners
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