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ISO 13485 for Medical Devices

Considering the sensitiveness of the pandemic situation the medical industries are coming up with new medication and ways to protect the nation from the adverse impact of this crisis. Businesses venturing into the medical line sector requires following certain standardized practices when it comes to the health and safety of patients. Therefore, ensuring the high quality of the medical devices is necessary to ensure accuracy, effectiveness, and control of the Medical devices necessary for customers, stakeholders, patients, users, and others.

Management of quality is an essential element in manufacturing medical devices ensuring adequate quality systems and product requirements are streamlined. Standardization of requirements promotes the safety and errorless function of medical devices.

What is Medical Device?

A medical device is an instrument, machine, implant, or in vitro reagent that helps the user to test or identify/diagnosis the diseases of the patient or user to prevent and treat the diseases, rehabilitation of illness, or other medical conditions.

What is ISO 13485 Certification?

ISO 13485 Certification for Medical Device Quality Management Systems is growing in popularity, with the increase in the number of certified industries. The ISO 13485 standard governs the Quality Management System for Medical Devices addressing quality control, risk management, operational efficiency, legal compliance and product process improvement using updated techniques and technology with the reduction in recalls of product and services.

Implementing QMS in the products and devices helps to ensure that the organization is binding the quality and effectiveness of the product and devices. That is why the international body ISO introduced ISO 13485 Standard to sets out the requirements of QMS for the medical device industry. ISO 13485 enables an organization to align or integrate with medical device industry requirements to address the requirements under EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations which consistently meet the customer and regulatory requirements.

At some point in time, due to any case of emergencies government and others prefer the certified organization to manufacture the devices or medicines for the safety of the public in the nation. To understand this requirement, many of the organizations or industries became ISO 13485 Certified to be in the market for the long run. The decision to define processes and procedures comprising a quality management system for your organization should bother with “we have to,” rather than a “we get to.” ISO 13485 is intended to help medical device manufacturers to provide them with the framework of step-by-step guidance and requirements for creating a QMS and/or evaluating gaps in your current system.

How Certifying to ISO 13485 Certification helps you?

ISO 13485 provides a foolproof quality check to demonstrate its commitment to building high-quality medical devices. The standard ensures that the functioning of the devices is as per their intended purposes with utmost safety. The most important result of ISO 13485 certification is reducing the risk of defective devices by protecting the health of consumers.

  • Many large medical device businesses prefer to work with vendors and subcontractors who conform to ISO 13485 standards. Helps to expand your business.
  • Achieving ISO 13485 Certification demonstrates to customers and regulators that your company values quality.
  • International medical device standards like ISO 13485 demonstrate the same reliability and quality in medical devices all over the world.
  • Help to improvise operational efficiency of the medical devices products, as you examine procedure and process to manage risks by increasing the traceability and consistency.
  • ISO 13485 helps you to continually improve your processes saving your organization money. Therefore it is a cost-saving
  • A medical device QMS helps you to make your products more reliable and better to meet customers’ needs.
  • Certification to ISO 13485 is a sign of a reputable business and high-quality products, so it can improve your business’s reputation.
  • ISO 13485 is an internationally accepted QMS for medical devices and helps to earn certification to ISO 9001, as the two standards share many requirements.

ISO 13485 specifies quality management for the medical device to ensure that companies meet ISO 134845 requirements when outsourcing the development, design, or servicing of a medical device.

ISO standards are voluntary, though implementation of ISO 13485 is also voluntary standard. So being certified to ISO 13485 isn’t obligatory. On the other hand, Canada and other requires manufacturers to achieve ISO 13485 certification dealing in class I, II, and III medical devices.

Achieving either ISO 13485 or ISO 9001 Certification is the foremost step to approval for a medical device in Europe. Products from ISO 13485 certified companies are more trusted in the marketplace.

Do you want to be ISO 13485 Certified?

ISO 13485 contains requirements that are beneficial for various types of organizations that manufacture medical devices or provide services that support medical device manufacturers. Some examples of organizations that use this ISO 13485 standard include:-

  • Medical device manufacturers, including makers of sterile and surgical medical devices
  • Companies that provide raw materials to medical device manufacturers
  • Organizations that provide services to manufacturers of medical devices manufacturers

To make the ISO 13485 Certification process simple and quick. Hiring a consultant will guide you and your business through the following steps to achieve ISO 13485 Certification by providing.

  1. Gap Analysis Training 
  2. Testing
  3. Documentation & Test Report
  4. Process Audit
  5. External Audit
  6. Certification and beyond

Ascent WORLD as a globally accepted Consultancy provider offers you proper training, guidance, inspection techniques, and ideology to incorporate ISO 13485 Certificate in your organization. We have experienced staff and professionals, and expertise in fulfilling the guidelines and compliance of the ISO 13485 Certification (QMSMD). Our worldwide presence will help you to access expertise Auditors in gaining and implementing the standard Quality Management System for Medical Devices. Get in touch today to enjoy the early benefits of ISO 13485 Certified. For more details contact us, we are available 24X7 to help our customers.

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