ISO 13485
ISO 13485:2016 – Quality management system – medical devices, the standard is specifically developed by international organisation for standardisation (ISO) for medical device manufacturers to ensure quality in it processes while developing medical devices, it is sort as a mandatory certification required to be performed by all medical device manufacturers across the globe. The standard requires exports to support organisation in achieving the ISO 13485 certification. ISO 134185 certification is a mark of quality and safety of medical device in which the process of producing the device is controlled and recognized by this implementation process of ISO 13485:2016 certification, we at CertBureau provide ISO 13485 certification to organizations that are involved in Implantable devices, in-vitro devices, non in-vitro and implantable devices, medical equipment, medical beds and many more.
CertBureau Booster panel of experts who can provide solution for quality management system – medical devices, we help the organisation to develop and establish the required quality controls, documentation inspections, customer focus, leadership aspects that are required as per the standard framework and provide continue support in maintaining the ISO 13485.
It is estimated that there has been an increase of 33.8% in ISO 13485 certification in UK alone in the year 2019, Since the world suffering from pandemic in recent times, the increase in medical device manufacturers achieving QMS-MD certification is evidenced worldwide, US FDA, EU markets Device manufacturers to be compliant with ISO 13485:2016 certification.
The standard requires the organisations to implement the following requirement in a medical device manufacturer facility.
- Legal and regulatory compliance is that are required for products based on country and customer requirements.
- Analysis of risks related to the product development and product realisation.
- Verification and validation of the processes in development of the product.
- Implementation of a systematic quality management system.
- Product Traceability and Product Recall system must be established.
What are the benefits of ISO 13485 certification?
- Compliance to all legal and regulatory requirement of the product.
- Supplier Recognition – larger companies work with companies which are certified with ISO 13485 certification.
- Enhanced customer Satisfaction.
- Proven Business credentials.
- Better risk management
- Reduce operating costs.
Bing the internationally recognised certification for quality and safety of medical devices, many countries have a requirement of achieving this certification prior to provision of products I suppliers to the companies of these countries, many of our customers who are priorly facing issues do turn on achievement of ISO 13485 have been benefited drastically due to the implementation of this standard providing them a recognition in the market for quality and safety of their product.
How much does ISO 13485 Cost? How much does ISO certification cost?
A common question amongst the customers of CertBureau is how much does ISO 9001 cost? How much does ISO Certifications cost? the answer is simple yet complex in its own way. The cost of any ISO 13485 Certification depends on organization itself. The organizations interest & participation is an important factor in costs. Other parameters that are involved in ISO 9001 Costs are company location, company scope of work or activities, company size, certification body, consultant quality.
Most of the organization do errors in selection of consultants and certification body, with CB we guide the organizations to understand the importance of a certification body acceptable for their scope of work and implementation details which help the organization to understand the process well in advance.
Many organisations also prefer to be certified for CE marking on their products along with ISO 13485, we at CertBureau provide product certifications like CE marking to our customers with solutions for technical documentation, postmarked surveillance, medical device file and many more in our implementation of the quality management system- medical device.
How to get ISO 13485 Certification? How to get ISO 13485?
ISO 13485 Certification is simple to be achieved, we at CertBureau help organization to achieve it. The process starts with registration with authorized CertBureau consultants who are recognized by all certification bodies and ISO Organization. CertBureau helps the organization then to understand the requirements and deliverable sin the project. Our methodology is defined in this link – METHODOLOGY. The CertBureau team will help you achieve the steps involved in the process as defined in the methodology. ISO 13485 Certification, Quality management system – Medical Devices Certification are provided by CertBureau worldwide, with regional representatives and offices CertBureau is an international consultant firm that helps organizations like you and induvial to achieve their standard requirements. Reach out to us here.
Why CertBureau? Why us?
CertBureau is an organization with many international offices which helps it to gain great experience and knowledge across the world, we meet, we interact with many organizations in many continents and countries. This helps us to bring in more creative and updated methods while implementation.
We have tried to provide some good points to help you understand why we could be us.
- CertBureau provides complete assistance to organizations wherein we take care of the organization standard requirements for three years or the standard life cycle.
- CertBureau is a company of locals when it interacts with organization, we have tried to provide presence worldwide so the representative will be one among you and not just us.
- CertBureau recognition is with vast number of certification bodies and lead auditor forums.
- CertBureau provides only local government acceptable certifications which helps us to retain the customer and have a hassle-free approval process for our customers.
- CertBureau has additional services like Tender Preparation Services, Corporate Skills training program, Team Building program which are free of cost to all our organizations because we strongly believe we will be only as good as the team we work with, and we look forward to growing with all.
- CertBureau offers a unique platform for all our customers to connect with our other customers in Know Our Customer section. More details are provided here.
CertBureau offers certification services at affordable costs, shorter timelines and regular follow up post service delivery which is a continuous effort that we believe would benefit us and our customers.