BAI has been equipped to help medical device companies with regulatory compliance since 2009. We offer a wide range of compliance services, including regulatory support, device registration, quality management system compliance, training, and documentation support.
We provide our clients with a single-window of regulatory compliance support, whether they are selling in one market or dozens of countries around the world. Our in-depth analysis helps to identify and address gaps in customers' processes, ensuring a robust foundation for compliance. We conduct a thorough review of client-specific technical documentation to meet Regulatory requirements.
BAI consulting services help medical device companies navigate the regulatory landscape and put robust QMS in place.
• Review & understanding of Company information and device-specific technical information like Intended Use, Device description, Model and variant details, device classification critical suppliers, QMS etc.
• Application support on the Sugam portal
• Gap Analysis
• Establishing Technical Documentation as per applicable Regulations like Schedule IV Annex I II & III, Risk Assessment, Clinical Evaluation Reports Usability, PMS, PMCF etc
• Design and develop QMS processes and procedures aligned with the organization's business objectives and compliance requirements with Schedule V/ISO 13485:2016.
• 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 the 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.
• Training, Audits & technical guidance
• Regular risk assessments, audits, and updates to QMS processes and procedures
• Technical guidance on Registering Devices in specific markets like India, the EU, US.
We are passionate about our work and how it translates into Return on Investment for our valued partners
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