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ISO 13485

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ISO 13485- Quality Management Standard

ISO 13485 is an international standard that specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements. It focuses on the safety and effectiveness of medical devices and is crucial for companies involved in the design, production, installation, and servicing of medical devices.

ISO 13485 certification is a cornerstone in the medical device industry, offering a range of benefits that significantly impact manufacturers. This certification symbolizes a commitment to meeting rigorous quality management system criteria, ensuring the safety, effectiveness, and reliability of medical devices. Tailored specifically for the medical device sector, the ISO 13485 standard surpasses previous benchmarks, making it an essential achievement for manufacturers aiming to excel in this highly regulated industry

Why Achieve the ISO 13485 Certification with AKSOFT Global Solutions?

Achieving ISO 13485 certification with AK Soft Global Solutions is a strategic choice for medical device manufacturers looking to ensure the highest standards of quality and compliance. Here’s why partnering with AK Soft Global Solutions is the right move.

Expertise in ISO Certification: With years of experience in ISO consulting and training, AK Soft Global Solutions brings unparalleled expertise in guiding companies through the complex certification process.
Tailored Approach: We understand that every organization is unique. Our team provides customized solutions that align with your specific business needs and goals, ensuring a smooth certification journey.
Comprehensive Support: From initial gap analysis to final audit preparation, AK Soft Global Solutions offers end-to-end support. Our services include training, documentation assistance, and ongoing consultation to help you meet and maintain ISO 13485 standards.
Proven Track Record: We have a history of successfully helping medical device manufacturers achieve ISO 13485 certification. Our clients trust us for our commitment to excellence and our ability to deliver results.
Global Reach with Local Expertise: Based in Houston, TX, AK Soft Global Solutions has a deep understanding of both local and international regulations, making us a trusted partner for companies looking to expand their global footprint.

What are the benefits of ISO 13485 certification?

Regulatory Compliance: Helps organizations comply with international regulatory requirements.
Risk Management: Enhances the ability to identify and manage risks throughout the product lifecycle.
Customer Trust: Builds trust with customers and stakeholders by demonstrating a commitment to quality and safety.
Market Access: Facilitates access to global markets, as many countries require ISO 13485 certification for regulatory approval.

FAQs about ISO 13485

To find more about ISO 13485, check out our section of Frequently Asked Questions (FAQs).

  • What is ISO 13485?
    ISO 13485 is an international standard that specifies requirements for a quality management system (QMS) specific to the medical devices industry. It ensures that organizations consistently meet customer and regulatory requirements applicable to medical devices and related services.
  • Who should implement ISO 13485?
    ISO 13485 is designed for organizations involved in the design, production, installation, and servicing of medical devices. It is also applicable to suppliers and other external parties providing products or services to these organizations.
  • What is the relationship between ISO 13485 and ISO 9001?
    ISO 13485 is based on ISO 9001 but includes additional requirements specific to the medical device industry. While ISO 9001 focuses on customer satisfaction and continual improvement, ISO 13485 emphasizes meeting regulatory requirements and maintaining effective processes.
  • Is ISO 13485 certification mandatory?
    ISO 13485 certification is not mandatory, but it is often required by regulatory bodies, customers, and stakeholders as proof of compliance with quality and safety standards for medical devices.
  • How long does it take to achieve ISO 13485 certification?
    The time required to achieve ISO 13485 certification depends on the size and complexity of the organization, as well as the maturity of its existing quality management system. Typically, it can take anywhere from 6 months to 18 months.
  • How often is ISO 13485 updated?
    ISO 13485 is periodically reviewed and updated to reflect changes in the medical device industry and regulatory requirements. The most recent version is ISO 13485:2016, which introduced significant changes to the standard.
  • Can small businesses achieve ISO 13485 certification?
    Yes, small businesses can achieve ISO 13485 certification. The standard is scalable and can be tailored to the specific needs and resources of the organization, regardless of its size.