We are very excited to announce the addition of Mia Spiegelman, B.Sc. RAQC to the NHP Consulting team as our new Director of Medical Devices and Pharmaceuticals. Educated in Israel, Argentina and Toronto, Mia brings to NHP Consulting over 16 years of experience in medical devices, generic drugs, cosmetics, pharmaceuticals, and natural health products. Mia’s extensive experience in the regulatory and quality fields includes work with over 80,000 products and an array of services. We are happy to use this experience to broaden service offerings to our clients and increase the value of our existing services, particularly our medical device offerings.
Medical devices in Canada are a diverse group of products that Health Canada organizes into four classes ranging from the lowest risk (Class 1) to the highest risk (Class 4). Devices can be as simple as a toothbrush (Class 1) or as complex as a pacemaker (Class 4). They can appear in liquid (in vitro diagnostic devices, IVDD), solid (most medical devices), or virtual (software as a medical device) formats, and a Health Canada medical device application is highly class and format specific. When planning to import, distribute, manufacture, package, label, or wholesale a medical device in Canada, our full service will help you find the best and most cost effective way of managing your devices in the Canadian market.
Prior to joining us at NHP Consulting, Mia’s most recent position was the Head of Regulatory and Quality at the largest importer and distributor of medical devices in Canada, and she has handled products and services ranging from endoscopes to dialysis machines; the importation and distribution of all classes of regulated products; and the servicing of complex medical devices. Her appointment to the head of our Medical Device and Pharmaceuticals division means we can now support not only the international registrations of your medical devices, but also assist in all aspects of a device’s life cycle, from concept and registration to manufacturing, quality-system design, and post-market reporting.
In addition to medical device product registrations, we can help you with your facility and quality systems. We now offer ISO13485 Support, including assistance selecting the right registrar for your product/company; implementation of ISO13485:2003 or ISO13485:2016; CMDCAS or MDSAP support; and guiding the transition between the above-noted systems. We can file applications for Medical Device Establishment Licenses (MDELs) and create standard operating procedures (SOPs) in compliance with Health Canada’s Medical Device Regulations. We also offer both paper-based and on-site audits for MDEL facilities, including ISO13485 and Health Canada preparedness evaluations/gap analyses.
Finally, NHP Consulting can assist you in your post-market activities related to medical devices. In the case of recalls, we can help you by completely managing the recall (contacting your customers and arranging all recall activities) or simply reporting to Health Canada the initiation and closure of recalls. We will work with you to find the best solution to your recall concerns, and stay with you until all aspects of the recall are resolved. When dealing with complaints related to medical devices, we can help you by both supporting the complete investigation or by managing the decision tree for report requirements to Health Canada.
We are delighted with the addition of Mia and these new services to our company. Please contact us for help in registering your medical devices; for fine-tuning your manufacturing or importing facility; or if you want to know anything more about our new services.