BUSINESS CONSULTING

We are dedicated to helping our clients achieve optimal business results. To this end, we offer a comprehensive suite of consulting services.

Key process consulting, digital consulting, business consulting services we offer include, but are not limited to:

• Risk Assessment : ISO 14971: We conduct comprehensive risk management assessments following ISO 14971 and other industry-standard frameworks to identify, analyze, and mitigate potential hazards throughout your product lifecycle. Our systematic approach evaluates operational, technical, and compliance risks, implements appropriate risk controls, and establishes ongoing risk monitoring processes. We help you build robust risk management documentation that satisfies regulatory requirements while protecting your business and stakeholders.

• Regulatory & Quality Compliance Checks: Navigate complex regulatory landscapes with confidence through our thorough compliance assessments. We evaluate your products and processes against industry-specific regulations, international standards, and quality requirements to identify gaps and provide clear remediation strategies. Our compliance checks cover documentation reviews, process evaluations, and quality system assessments to ensure your operations meet all necessary standards and market requirements.

• Reliability Checks and Adherence to International Standards (IEC, ISO): We assess your products and systems against critical ISO, IEC standards such as IEC 62304, IEC 60601, ISO 13485, and other relevant specifications. Our reliability assessments evaluate performance, safety, security, electromagnetic (EMI / EMC) and magnetic resonance (MR) compatibility, software lifecycle processes, and quality management systems. We provide detailed gap analyses and implementation guidance to ensure full compliance with international requirements and industry best practices. 

• Human Factors, UI / UX Design Assessment: Optimize user experience and operational effectiveness through comprehensive human factors engineering evaluations. We assess user interfaces, workflows, and interaction designs to identify potential usability issues and areas for improvement. Our assessments follow established usability principles and industry guidelines including IEC 62366 standards, providing evidence-based recommendations to enhance user experience while minimizing operational risks and errors.

• Design Control and Manufacturing Process Assessment (Lean Manufacturing and GMP): Ensure your design controls and manufacturing processes meet quality requirements while maximizing efficiency. We evaluate your design control procedures against standards like ISO 13485, assess manufacturing processes for compliance and optimization opportunities, and identify areas for lean manufacturing implementation. Our assessments help you build quality into every stage of your product lifecycle while improving operational efficiency.

• Hardware and Mechanical Design Assessment: Our experienced engineers conduct thorough evaluations of your hardware and mechanical designs to ensure performance, reliability, and manufacturability. We assess material and component selection, system architecture, mechanical designs, and environmental considerations while verifying compliance with applicable standards. Our assessments identify potential design improvements and validate that your hardware meets intended performance specifications and industry requirements.

• Biological Assessment for Class I, II (a & b), and III Medical Devices: We provide comprehensive biological safety evaluations following ISO 10993 standards and other relevant guidelines. Our biological assessments evaluate safety risks, determine appropriate testing requirements, and develop comprehensive safety documentation packages. We help you navigate the complexities of biological evaluation while ensuring safety and regulatory compliance across different product categories and risk levels.