How long does it take to get ISO 13485 certification in Nigeria?

ISO 13485 Certification in Nigeria rapidly changing healthcare landscape, making sure that the quality and safety of medical devices are not a matter of choice. For businesses located in Nigeria engaged in the development, production or installation of medical equipment, attaining ISO 13485 certification in Nigeria is an essential step towards international competitiveness and regulatory conformity.

What is ISO 13485?

ISO 13485 is an internationally accepted standard developed in collaboration with the International Organization for Standardization (ISO). It specifies the specifications for creating a QMS (QMS) specific to the medical device industry. It is focused on process control, risk management, product traceability, and legal compliance throughout the product’s life cycle.

Why is ISO 13485 Certification Important in Nigeria?

With the ISO 13485 Certification in Nigeria medical and healthcare device industry on the rise, ISO 13485 Certification in Nigeria offers several benefits:

• Regulation Compliance: Helps to meet NAFDAC (National Agency for Drug and Food Administration and Control) and international regulations for medical devices.
• Market expansion allows access to international markets such as the the EU, US, and Middle East, where ISO 13485 Certification in Nigeria is typically required.
• The Customer’s Trust Shows an unwavering dedication to safety, quality and continual improvement.
• Operational efficiency is a method of streamlining and standardizing processes.

Who Should Get ISO 13485 Certification in Nigeria?

• Medical device manufacturers
• Distributors and importers of medical devices
• Component suppliers
• Sterilization and packaging providers
• Laboratory for calibration and testing
• Diagnostic and hospital centers for diagnostics (in some instances)

Key Requirements of ISO 13485

• Implementation of a strong Quality Management System
• Controlling records and document control
• The management of risk throughout the lifecycle of a product
• Post-market surveillance and compliance with regulations
• Effective internal audits, as well as CAPA (Corrective and Preventional actions)

Steps to Get ISO 13485 Certified in Nigeria

1. Gap Analysis Review your current system regarding ISO 13485 Certification in Nigeria requirements.
2. Training: Inform your team members of the requirements of the standard.
3. QMS Application: Create and document the procedures and processes that are required
4. Internal Audit: Assess the efficiency of your QMS
5. The Management Review – Involve the leadership and ongoing improvement.
6. A certified certification body –conducts Certification Audit Audits.
7. Certification Issued – Upon successful Audit, receive your ISO 13485 certificate.

How FactoCert Can Help

With FactoCert, we are experts in helping Nigerian businesses achieve ISO 13485 Certification in Nigeria seamlessly. We offer the following services:

• Expert gap analysis
• End-to-end support for documentation
• Internal auditor training
• Certification body liaison
• Post-certification Support

We know the local regulatory environment and international compliance standards, making us the ideal partner for certification.

 Just drop an email at contact@factocert.com. Want to know ISO 13485 Certification in Nigeria cost in India, get a free quote from us.

For More Information Visit: ISO 13485 Certification in Nigeria