MTI life scienceS

Strategic Advisory:

• Quality Management Systems, Process Implementation, Improvements and Harmonization

• SaaS Governance and IT Compliance

Systems Implementation :

• Program and Project Management

• Computer Systems Validation

• Vendor System Selection

• Request for Proposal (RFP) development

Audit, Regulatory Compliance and Remediation:

• GxP / Hosted Solutions, Vendor Audits

• Quality Management Systems Audits

• Data Integrity Evaluation and Remediation

• ERES (21 CFR Part 11 / Annex 11) compliance assessment and remediation

• GDPR / NIST Cybersecurity Certification

• CAPA and Consent Decree Remediation

• AI Compliance

MTI Managed Services

• Audit Readiness

• Audit Support (we’ll sit in the audit with you to defend our approach, processes and deliverables)

• CRO / CMO Vendor Qualification

• Internal Audit and Periodic Review

• Ongoing Change Management (including Impact Assessment and Validation of Releases, etc.)

MTI automation & Software design

• Requirements Gathering

• Software Design and Development

• Software Project Management

• Software Testing

• Software Implementation (cloud or on-premises)

• Automate / develop compliance processes based on regulatory compliance and industry guidance using our no-code platform Easy-GxP

GxP CLOUD COMPLIANCE

• Cloud Platform Qualification

• Cloud Software Validation

• Release Management for Cloud Systems

• Change Control

• External Audit Support

• Validation Client Support (IQ / OQ / PQs)

• Creation and Management of Requirements

Medical Devices Consulting

• Regulatory Compliance: Providing guidance on navigating FDA regulations such as 21 CFR Part 820.

• Quality Management Systems (QMS): Assisting with the development, implementation, and maintenance of QMS according to regulatory standards.

• Risk Management: Helping to identify, assess, and mitigate risks associated with medical device development and manufacturing.

• Design Controls: Offering expertise in managing the design and development process to meet regulatory requirements.

• Quality Audits: Conducting internal audits and supplier audits to assess compliance with regulatory requirements.

• Training and Education: Offering training programs to educate staff on regulatory requirements and best practices.