BSI is a leading global organization with technical expertise and experience from a notified body for medical device technologies and products worldwide.
National Therapy is your trusted Medical Device Manufacturer in Toronto & Canada. We supply our customers with the top Beauty Products & Medical Devices.
The FDA therefore launched a precertification pilot program in 2017 for companies wishing to expedite the medical device certification process, with Fitbit and Samsung among those selected to take part. Smaller startups can still achieve medical device status by conducting clinical trials and presentin...
The market for medical devices in Canada has experienced rapid growth, making Canada a prime market for medical device manufacturers. This is especially so since imported medical devices account for a large percentage of all medical devices sold in Canad...
In addition, in April 2021, NeuroMetrix, Inc. partnered with Pacific Northwest-based Premera Blue Cross to launch the new Quell wearable device to treat pain caused by chronic ailments. Other players operating in this market include Sonova, OMRON Corporation, BD, and NeuroMetrix Inc. These compan...
BSI is enthusiastic about the use of hybrid medical device audits. Part of the audit offering remains in-person and onsite, but a large proportion is now delivered remotely.
As a medical device manufacturer, by choosing to work with BSI, you will benefit from our team of experienced, professional, and well-qualified in-house experts with a wide range of regulatory and technical expertise. We have extensive hands-on experience in all aspects of the device life cycl...
BSI Medical Devices provide comprehensive regulatory and market access services so medical device manufacturers can stay compliant and sell into global markets.
Thefollowingpersonsare?exempt?fromholdinganMDELtoimportintoorsellamedicaldeviceinCanada: anypersonwhoimportsamedicaldevicefortheirownpersonaluse retailers,including: companiesthatsellmedicaldevicestotheenduser(orultimateconsumer)fortheirownpersonaluseor manufacturersofClassImedicaldevicesinCanadawhoselltheirdevicessolely...
In the competitive medical device market place, ensuring that medical device product development meets all regulatory requirements is essential.