50% deviation
reduction in 90 days
At Affirm8, we help life sciences businesses simplify compliance, strengthen systems, and embed a culture of continuous improvement.
Whether you’re preparing for ISO certification, modernising outdated processes, or empowering your team, our tailored solutions are built to move you forward - not hold you back.
QMS Strategy & Implementation
We build ISO-compliant Quality Management Systems (QMS) tailored to your operations - practical, scalable, and aligned with regulatory standards.
Includes:
- ISO 9001 & ISO 13485 system design
- Standard Operating Procedures (SOPs)
- CAPA and document control
- Certification readiness support
Internal Audits & Gap Assessments
Training & Capability Building
Digital Quality Solutions
The A‑Grade Method. A five-step cultural transformation process that builds momentum, sharpens quality, and sustains results.
Activate
Align teams on purpose, urgency, and possibility. Spark momentum through cultural friction diagnostics.
Assess
Deep-dive into deviation, CAPA, and QMS trends. Uncover the true roots of lagging quality performance.
Affirm
Identify wins, strengths, and existing good practices to amplify. Build confidence before correcting.
Accelerate
Run guided 90-day sprints to improve quality culture and reduce deviation backlogs with momentum.
Advance
Sustain results through habit architecture, leadership enablement, and continuous learning systems.
Some of our happy clients
