QMS & audit support
Gap assessments and closure for ISO 13485 and customer audit preparation.
Medical Equipment
QMS alignment, BGV, and HR for medical device and equipment manufacturers.
Device quality starts with people and process discipline.
Medical equipment makers work under ISO 13485, regulatory filings, and customer audits where documentation and trained personnel are non-negotiable.
Eyewynk supports quality system readiness, role-based verification, and HR practices that match the rigour medical device production demands.
Sector challenges
Regulatory QMS
Design controls, CAPA, and training records must be demonstrably current.
Clean production areas
Assembly and testing zones need access control and hygiene discipline.
Skill certification
Operators and inspectors must be qualified for specific product families.
Supplier quality
Incoming components and subcontract steps need verified partners.
How Eyewynk helps
Verification & HR
BGV for production and quality roles; payroll and registers aligned to QMS training matrices.
Operational discipline
4M on assembly and test lines; standard work for high-mix medical SKUs.
Typical services in this sector
ISO 13485 audit preparation
BGV & investigation consulting
HR outsourcing & payroll
Training matrix implementation
4M on assembly lines
Legal & compliance advisory
Engagement highlight
Medical device assembler · Pune region
Challenge: Notified body audit found training matrix gaps for new product line operators.
Outcome: Matrix and records rebuilt in 30 days; certification audit continued without hold.
Engagements are scoped for measurable outcomes—audit readiness, workforce stability, line efficiency, or project milestones—with steering reviews agreed upfront. ISO 9001:2015 certified Eyewynk standards apply across every sector we serve.
Let's talk about your challenge
Payroll, compliance, training, HR outsourcing, audits, or 4M mapping — tell us what you need. We'll respond within two business days.