Introducing medical devices to the international market is a challenging task. The product must go through vigorous medical equipment testing before it can be officially released in the market. Since there is no room for error in the production of medical equipment, it is imperative to ensure an adequate quality management system at each step of the production.
Intertek’s medical material testing services offer third-party system verification carried out by highly trained medical professionals. Intertek is among the most trusted medical device testing and certification companies. Our expertise and services have helped organisations around the globe to successfully launch quality medical equipment.
Our medical tester is recognised globally because it’s carried out by medical device experts who do not influence any aspect of Intertek Notified Body and Certification activities.
Overview Of Our Medical Device Assurance Testing, Certification, And Auditing
Intertek’s medical device auditing and certification services include:
1) ISO 13485 – Quality Management System For Medical Devices:
Around the globe, ISO 13485 is regarded as a global standard to maintain the quality of medical devices. It is a framework which manufacturers, designers, and suppliers must follow to ensure an adequate standard of medical equipment. Medical device testing also reduces the risk factor for all stakeholders. ISO 13485 tests medical devices for quality, safety, and ensures that a product or service being offered has a sustainable success. The global competition is at its peak, and if you are slow to improve, your competitor will easily take an edge over you.
2) Medical Device Single Audit Program (MDSAP):
Individual medical device regulators came together to develop MDSAP. The purpose of this is to give access to third-party auditors and medical device testing laboratories to audit medical device manufacturers to ensure medical device requirements are met. Intertek also enjoys recognition as a Medical Device Single Audit Program Auditing Organisation (AO). The other participants of the single audit programs are America, Canada, Australia, Japan, and Brazil. It’s been around half a decade since Intertek became part of MDSAP. Since then, teams of trained auditors with experience and skills in the field has made Intertek an authorised auditing organisation.
Certification showcases your credibility in front of your customers. Intertek’s testing and certification services enjoy global accreditations and recognition. The global audience wants a product that is safe, reliable, and environmentally friendly. A certification from Intertek displays a correct portrait of your product in front of your audience. Our experience in the field keeps you a step ahead of your competitors and brings you the most effective solutions.
Getting assurance is a key step to ensuring all the underlying elements are up to the standard. The assurance makes a company and its products successful. Being a leader in medical equipment testing, Intertek’s assurance makes sure your procedures, systems, and people are following the guidelines that make your product safe and keeps you a step ahead of your competitors. The in-depth auditing, exclusive performance, and supply chain services keep you updated about every tiny bit of your operations allowing you to make informed decisions regarding your business.
Schedule a free risk assessment: https://compliancetesting.com/schedule-consultation/
If you have any query, feel free to ask us anything: https://compliancetesting.com/contact/