QMS Implementation (QSR / ISO): Guidance on implementing Quality Management Systems aligned with QSR and ISO standards.

Audits and Assessments: Conducting audits of QMS, suppliers, and training to identify compliance gaps.

Development of SOPs and Process Guidelines: Creation of Standard Operating Procedures and process documentation to meet regulatory and operational requirements.

Integrated QMS Solutions: Development of QMS platforms integrated with digital tools to streamline documentation and audits.

Internal Training Programs: Tailored training for teams to ensure understanding and implementation of QMS processes.

Document Control and Change Management: Systems to manage revisions and approvals for controlled documents.

QMS Maintenance and Optimization: Ongoing evaluation and enhancement of QMS to adapt to changing regulations and business needs.

Pre-Market Submissions (510(k), CE Marking): Preparation and submission of pre-market documentation to secure regulatory approvals.

Regulatory Strategy & Compliance Plan: Development of a tailored roadmap for adherence to healthcare regulatory standards.

DHF and TD Gap Analysis: Comprehensive evaluation of Design History Files and Technical Documentation to ensure compliance.

Design Verification and Validation Services: Comprehensive testing and certification for systems, subsystems, and compliance.

Computer Systems and Software Validation: Validation of computer systems and software per FDA regulations to ensure security and data integrity.

Risk Management (ISO 14971 Compliance): Comprehensive services for hazard analysis, FMECA, and FTA to meet ISO 14971 standards.

Human Factors Engineering (HFE): Conducting usability testing and risk analysis to align with FDA and MDR requirements.

Design Failure Mode and Effects Analysis (DFMEA): Facilitating design-level risk assessments to mitigate potential issues early.

Reliability Engineering: Ensuring the device maintains performance and safety over its intended lifecycle.

System Integration Testing: Validation of interactions between software, hardware, and other subsystems.

Risk-Based CAPA Implementation: Prioritizing corrective actions based on risk levels to ensure efficient issue resolution.

Compliance to IEC 60601-1: Gap analysis, compliance testing, and certifications for IEC 60601-1 requirements.

Compliance to IEC 62304: Assistance with software lifecycle management for medical devices as per IEC 62304.

ISO 13485 Certification Support: Assistance in achieving and maintaining ISO 13485 certification.

Cybersecurity Compliance (FDA and EU): Ensuring secure device design and protection against cyber threats.

Interoperability Standards Compliance: Aligning devices with standards like HL7 and FHIR for seamless data integration.

Supplier Engineering: Ensuring supplier compliance with quality and regulatory standards.

CAPA (Corrective and Preventive Actions): Management and documentation of CAPA processes to enhance product quality.

Supplier Qualification Audits: Comprehensive assessments to qualify new suppliers and mitigate supply chain risks.

Supplier Relationship Management: Creating and maintaining agreements to ensure compliance and quality performance.

Lean Manufacturing Process Audits: Identifying inefficiencies and optimizing manufacturing workflows for compliance and productivity.

Vendor Risk Assessment: Ongoing evaluation of supplier risks, including geopolitical and logistical factors.

Data Privacy & Protection (US/EU): Ensuring adherence to US and EU data privacy regulations.

Data Integrity Audits: Evaluating data systems for consistency, accuracy, and compliance with regulations like GDPR and HIPAA.

Cybersecurity Risk Assessments: Identifying and mitigating potential vulnerabilities in digital health solutions.

Incident Response Planning: Creating robust protocols to manage and report data breaches effectively.

Global Data Transfer Compliance: Guidance on cross-border data flows and compliance with international data protection laws.