If your company manufactures medical devices or components, supplies medical packaging, or provides sterilization or testing services, your customers will ask one question:
“Are you ISO 13485 certified?”
Without it, you lose global business opportunities. With it, you gain trust, compliance, and international market access.
ISO 13485 is the international Quality Management System standard for medical devices. It ensures product safety, risk control, process consistency, and regulatory compliance—which is mandatory to meet CE Marking (Europe), FDA 21 CFR 820 (USA), Health Canada, and other medical regulations.
Our ISO 13485 Consulting Approach – Practical, Regulatory-Compliant & Audit Ready
At Greendot Consulting, we believe certification should add value, not paperwork. We build systems that work on the shop floor, not just the audit table.
ISO 13485 applies to any organization in the medical device supply chain, including:
In short, EcoVadis is no longer optional – it’s becoming the entry ticket for global business.
ISO 13485 applies to any organization in the medical device supply chain, including:
Category | Examples |
Medical Device Manufacturers | Syringes, surgical instruments, hospital beds, ventilators |
Medical Equipment | Dental chairs, suction units, lab analyzers |
Component Suppliers | Plastic molded parts, tubes, rubber seals, metal machined parts |
Sterile Packaging | Blister packaging, medical pouches, cleanroom packaging |
Contract Manufacturers | OEM contract assembly & fabrication |
Sterilization & Testing Services | ETO sterilization, gamma, validation labs |
Healthcare Software | Embedded medical device software |
Orthopedic & Implants | Knee implants, spine systems |
Disposable Medical Products | IV sets, cannulas, gloves |
If you supply medical OEMs or export products, ISO 13485 is non-negotiable.
At Greendot Consulting, we believe certification should add value, not paperwork. We build systems that work on the shop floor, not just the audit table.
Our 7-Step Implementation Roadmap
Baseline against ISO 13485 & regulatory needs
FMEA, risk control, product safety
SOPs, Device Master File, Technical File, Traceability
Process validation, calibration, monitoring
Regulatory documentation compliance
Nonconformance handling, continual improvement
Audit preparation, handholding, closure support
Different industries are already feeling the impact:
At Greendot, we act as your coach and guide – helping you not just submit data, but improve your score and stay competitive.
Our 6-step approach:
ISO 13485 applies to any organization in the medical device supply chain, including:
Category | Examples |
Medical Device Manufacturers | Syringes, surgical instruments, hospital beds, ventilators |
Medical Equipment | Dental chairs, suction units, lab analyzers |
Component Suppliers | Plastic molded parts, tubes, rubber seals, metal machined parts |
Sterile Packaging | Blister packaging, medical pouches, cleanroom packaging |
Contract Manufacturers | OEM contract assembly & fabrication |
Sterilization & Testing Services | ETO sterilization, gamma, validation labs |
Healthcare Software | Embedded medical device software |
Orthopedic & Implants | Knee implants, spine systems |
Disposable Medical Products | IV sets, cannulas, gloves |
If you supply medical OEMs or export products, ISO 13485 is non-negotiable.
Without ISO 13485 | With ISO 13485 |
Lose export orders | Enter global markets with CE / FDA acceptance |
High product failure risk | Improved product safety |
Poor documentation & traceability | Process control + traceability system |
No regulatory compliance | Meets MDR, FDA, global regulations |
Low buyer trust | Strong customer confidence |
Our ISO 13485 Consulting Approach – Practical, Regulatory-Compliant & Audit Ready
At Greendot Consulting, we believe certification should add value, not paperwork. We build systems that work on the shop floor, not just the audit table.
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