![bsi iso 13485 bsi iso 13485](https://demo.dokumen.tips/img/380x512/reader022/reader/2020082822/5f329344a032dc7adc2f97a5/r-2.jpg)
![bsi iso 13485 bsi iso 13485](https://www.oxebridge.com/emma/wp-content/uploads/2018/02/BardPeripheralVascularISO13485BSI.jpg)
Get more information about CE marking with BSI, at Learn more about QMS certification with BSI, at Visit our MDSAP webpage to learn more about the programme, at View our full medical devices training portfolio, at /en-GB/medical-devices/training. Talk to BSI today and learn more about market access with our certification services, training and product testing through our strong alliance partner. It is critical to work with a leader that understands the industry and has the experience to review and confirm the product's readiness for market - efficiently, reliably and promptly. With increasing scrutiny of medical devices and a changing regulatory landscape, it's essential to ensure that your product meets all regulatory and quality requirements before launch. We now operate in over 180 countries, and our team of specialists is based around the world, with a combined experience in excess of 2,800 years. We offer truly global solutions that ensure patients have access to safe and effective devices.įor more than 100 years, BSI's expertise has provided an assurance of safety and quality to manufacturers. our Regulatory & Compliance division, we are able to ensure ISO 13485:2016 and FDA Compliance (21 CFR Part 820). A recognised Conformity Assessment Body and Certification Body in markets including Japan, Malaysia and Taiwan.A recognised Auditing Organization under MDSAP.A UKAS-accredited ISO 13485 Certification Body.The world-leading full-scope Notified Body for CE marking.We assess manufacturers for conformity to market access requirements as: Through the passion and expertise of our people, BSI has become a leader in medical devices market access, delivering robust product and system certification that stands up to scrutiny and delivers confidence. We strive to set the global standard in thorough, responsive, predictable conformity assessments, evaluations and certifications. Our mission is to ensure patient safety while supporting timely access to global medical device technology. It is essential that your Certification Body has the capability and expertise to support you with robust product and system certification reviews, to ensure patient and user safety. BSI is an established Certification Body for many market access schemes, including the leading Medical Devices Notified Body for CE marking.
#Bsi iso 13485 verification#
In many cases, verification of your compliance must be completed by a third party assessor, or Certification Body. BSI Medical Devices: Meet the world with confidenceĪs a medical device manufacturer, there are a number of regulatory and quality requirements you must meet before you can sell your devices on the international market.