Massachusetts
Our Services
Compass Life Science Solutions has a well-established staff with extensive experience in the life science industry spanning multiple areas of expertise. Our expertise includes:
- Clinical Evaluation Report (CER) Authoring
- Guidance on complying with President’s Executive Order (EO) on Improving the Cybersecurity of the Federal Government (EO 14028)
- Cybersecurity assessments for computerized systems and medical devices to ensure data and diagnostic result integrity
- Reviews of computerized system and medical device data encryption, end-to-end data security controls, and communication protocols protecting information throughout the communication process
- Advising executives on critical compliance needs, risk mitigation strategies, remediation plans, Regulatory Agency expectations, and the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
- Assisting clients in composing responses to Inspections and Regulatory Actions, such as Warning Letters
- Preparing organizations for regulatory audits related to MDSAP, US-FDA, EMA, MHRA, Health Canada, NMPA China, and HIPAA
- Providing clients with GxP Quality Assurance support to ensure compliance with current regulatory expectations
- Helping clients to achieve compliance with data integrity in relation to US-FDA, MHRA, and EMA guidance and regulations
- Providing clients with submission support
- Performing due diligence audits for clients
- Providing training and performing audits related to 21 CFR Part 11, 58, 210, 211, 312, and 820, Annex 11 and 15; ISO 9001, 10993, 12207, 13485, 14971, 15288, 19011, 27000, and 62304; HIPAA; CAPA; GAMP; IVDR; MDR
- Implementing client quality systems (i.e. Quality Manual, risk management, vendor management, record retention, CAPA, design control, production and process controls, acceptance activities, nonconforming product, document management, product identification and traceability, purchasing controls, etc.)
- Assisting clients with GxP computer system validation including software development and testing
- Assisting clients with General Data Protection Regulation (GDPR) Compliance
- Assisting clients with IT Governance Processes (i.e. Bring Your Own Device (BYOD), Acceptable Use Policy, Procurement, Logical and Physical Security, Service Management (ITIL Based), Account Management, Business Continuity Planning, Disaster Recovery, etc.)
- Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) compliance, development, and validation
- Technical writing including SOPs, WIs, test script writing, validation documents, etc.
- Project management services
- Test execution
- Performing quality control reviews of clinical documentation for regulatory submissions including protocols/amendments, clinical study reports, Investigator's Brochures, CTD modules 2 & 5