ISO 13485:2016 Certification (Medical Devices QMS)

ISO 13485:2016 के अंतर्गत हम medical device manufacturers, importers, distributors और service providers को Medical Devices Quality Management System (QMS) के अनुसार प्रमाणन प्राप्त कराने में पूरी सहायता प्रदान करते हैं। यदि आप product safety, regulatory compliance और traceability को मजबूत करना चाहते हैं, तो हमारी team gap analysis से लेकर documentation, implementation और audit coordination तक end-to-end support देती है। पूरी प्रक्रिया internationally recognized ISO standard के अनुसार होती है और ISO 13485 Certification in Gorakhpur के लिए professional assistance उपलब्ध है।

⭐ Benefits of ISO 13485:2016

• medical devices की safety और performance assurance

• regulatory readiness (India & global markets)

• risk management और product traceability

• tenders, hospitals और international buyers में eligibility

• brand credibility और market access में वृद्धि

📋 What We Do

इस service के अंतर्गत हम निम्न कार्य करते हैं:

• ISO 13485:2016 Gap Analysis

• Medical Device QMS documentation (policies, SOPs, records)

• Risk management (ISO 14971 alignment)

• Design & development controls (यदि applicable)

• Supplier control, validation & change management

• Training, internal audit & management review support

• Certification Audit coordination (Stage 1 & Stage 2)

• Certificate issuance तक complete follow-up

📑 Documents Required

• Organization profile & scope (device categories)

• Quality manual, procedures & records

• Risk management file

• Design history file (DHF) / technical documentation

• Supplier evaluation & purchasing records

• Complaint handling, vigilance & CAPA records

(documents organization size, device class और scope पर depend करते हैं)

⏱ Turnaround Time

4–8 Weeks
(readiness, scope और audit schedule पर depend करता है)

✅ Key Benefits

• ⚡ Structured QMS Roadmap – step-by-step implementation

• 🧾 International Recognition – globally accepted medical devices standard

• 👨‍💼 Expert Assistance – documentation, training & audits

• 💰 Transparent Fees – clear pricing, no hidden charges

• 📲 Regular Updates – Call और WhatsApp support