ISO 13485 Certification: Internationally recognized Quality Management System for Medical Devices
Improve the quality of your Medical Devices and Save more lives by achieving ISO 13485 Certification in Maldives and Male.
What is ISO 13485 Certification?
Medical devices are critical devices as it is directly related to the health of the user. It is the most regulated vertical in the world. By following stringent requirements, device quality must satisfy the need of the user or customer as well as meet the regulatory requirements before placing them in the market.
This standard is a guideline for quality business practices that focuses explicitly on organizations’ quality management systems (QMS) in relation to medical devices or related services. The ISO 13485 standard specifies the requirements to develop and maintain the quality of the devices as per technology updates and techniques. It systematizes processes that may already meet the comprehensive requirements for a QMS in the medical device industry.
When the risk to human life reaches CAT II or above then a few additional directives by the EU or FDA CFR have to be followed by the organizations that are using such devices. For Example: An orthopedic doctor using a steel rod or a cardiologist using a pacemaker come under a highly critical category of devices and require additional directives. Adopting ISO 13485 and implementing these Directives help an organization to conduct its operation. The ISO 13485:2016 standard aligns with the older version of ISO 9001 i.e. ISO 9001:2008. ISO standards are reviewed every 5 years to find out if any revision is required in order to be relevant for the current time. ISO 13485 standard is the parallel standard with the purpose to maintain Quality Management System for Medical Devices.
Benefits of ISO 13485 Certification
Achieving ISO 13485 Certification helps an organization in the long run in the following ways:
- Product Improvement
- In avoiding recalls and errors
- Helps in improving test and business performance
- Provides commitment to customers for the quality
- Improve access to the worldwide market with ISO 13485Certification
- Meet customers’ expectations
- Helps to compliance regulatory requirements
- Usage of updated technology
- Enhance marketability and creditability
- Provide confidence and improve the morale of the employees
Why do you need ISO 13485 Certification in Maldives?
Small factors can lead to bigger issues when organizations are not aware of the potential hazards of medical devices. Surgical tools and Machinery are critical to the diagnosis and treatment of patients; a minor mistake can take away the life of people. This is why it is crucial to establish Quality Management System for Medical Devices.
Achieving an ISO 13485 certification has significant benefits to the organization as well as to the customers. It systematizes processes and mitigates risk by ensuring your product quality. ISO 13485 Certification is the common path to meeting requirements to market and sell your device worldwide. With a proper system in place and along with the certification, assurance can be provided that the organization is able to provide medical devices & related services that consistently meet customers’ expectations and regulatory requirements.
Requirements of ISO 13485 Certification
ISO 13485:2016 specifies a Quality Management System for Medical Devices to meet customer’s needs and applicable regulatory requirements. ISO 134845 Certificate helps an organization to apply conditions equally to associated services supplied by the organization.
- Maintain the requirements for the Quality Manual, Control of Documents, and Control of Records for effective QMS
- Develop plans and policies to implement ISO 13485 standard in an organization
- Control and develop all resources, including human resources, buildings, and infrastructure
- Establish product requirements review to monitor and measure the product or service.
- Evaluate performance with continual improvement in QMS for Medical Devices
- Conduct Internal Audit
Which Organization needs ISO 13485 Certification?
It can be used by an organization involved in one or more stages of the life cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support). The requirements in this standard can also be used by suppliers or other external parties providing products (e.g. raw materials, components, subassemblies, medical devices, sterilization services, calibration services, distribution services, and maintenance services) to such organizations can also use the requirements in this International Standard.
Strength of Ascent MALDIVES
- We at Ascent MALDIVES have helped over 6000 management systems to put their business in the place.
- We at Ascent have been serving in this field of Management Systems Standards, Product Marking Certifications, and ISO 13485 Training for more than a decade with vast knowledge of the ISO 13485 compliance standards.
- We have well-qualified professional and competent Consultants who understand your business and technical needs and can help you with the practical and pragmatic approach to developing ISO 13485 Certification standard requirements and Certification with proper guidance and training of your personnel.
- Over the years with this approach, we have been enjoying the positive market value that has helped us win numerous service awards and helps in gaining the trust of our clients and customers.
- We at Ascent do not mislead you with any hidden charges.
- We provide the best quote that suits your pocket and achieves excellence in your work.
- We at Ascent enjoy a 100% success rate with certifications and audits.
- Ascent Maldives is available to help you 24*7 to solve your queries- complete hand-holding.
- We follow Plan-Do-Check-Act to remove hindrances in achieving the ISO 13485 certification.
- We provide you with the best quote to value for money-including internal and external audit costs with no extra charges.
- Our successful existence in this competitive market for more than 20 years, suggests our expertise in this field.
- Correct and appropriate Standard Interpretation, without any use of any bureaucracy.
- Consultants related to this field are generally an individual who is not very responsible for an answer if problems persist after the payment. But Ascent Maldives is one of the very few companies working as an organization and a group of experienced personnel having professional principles; we are a genuine company with authenticity meant to serve till the end.
Email your business information to mloffice@ascentworld.com or make an appointment for a meeting. After evaluating your business we will get you the real cost, involvement patterns, and timelines, for implementing and acquiring ISO 13485 Certification.
Frequently Asked Questions
What are class 1, 2, and 3 medical devices?
Medical devices according to FDA or EU Regulations are divided into various categories based on Product Risks ex. CAT 1 / CLASS I (Devices with low-moderate risk to the consumer require general control; CAT 2 / Class II (Devices with moderate-high risk require special controls); CAT 3 / Class III( Device with high risk supporting life or sustaining life).
What is the cost of applying for ISO 13485 Certification in the Maldives?
The cost of this standard is a little higher than the cost of other standards related to quality management as it is a very crucial standard dealing with the safety of medical devices and consumers’ life. It depends on the type of device you are dealing with and the need to acquire Certification.
IS ISO 13485 Certification mandatory?
ISO 13485 certification is mandatory in some countries for some kinds of products. Nevertheless, obtaining ISO 13485 Certificate is safer and more effective to deal with medical products.
How long does it take to acquire ISO 13485 Certification?
Depending upon the strength of an organization it approximately takes 3-6 months for companies.
What is the validity of the ISO 13485 certificate?
ISO 13485 certification is valid for 2 (Three) years from the date of issue of the certificate, subject to a successful annual surveillance audit at the end of the first and second year.
What is the difference between ISO 9001 and ISO 13485?
ISO 9001 Certification is an international standard for Quality Management systems for all types of industries whereas ISO 13485 Certification is a Quality Management System for medical devices.
Is it necessary for an organization to have ISO 13485 if they want to apply for the CE mark of any medical device?
ISO 13485 is the QMS standard accepted as the basis for CE marking medical devices. CE Marking is the product Certification and ISO 13485 is the basic requirement for an organization.
What does obtaining ISO 13485 Certificate mean?
A) Obtaining and maintaining ISO Certification is but a section of the whole business plan.
B) Focuses on the practices the business employs to maintain quality within the company.
C) Set the structures within which the operations function.
