(2797) achieving full-scope designation under MDR and IVDR. We are also a full-scope UK Approved Body (0086) assessing medical devices and IVDs against UK legislation. We review your medical device to ensure conformity against the relevant Regulations by offering a range of flexible product ...
Work smarter with the only platform designed by regulatory experts to manage your compliance process. Compliance Navigator is the only digital, multi-user platform currently available for managing the compliance process for medical device and in-vitro diagnostics products. ...
Learn about the FDA’s delay of MoCRA GMP to October 2025 and discover how cosmetic companies can prepare for compliance with MoCRA regulations. ...Read more Quality Smart SolutionsDecember 18, 2024 Blog What Are FDA Medical Device Classes?
Regulatory submissions and life cycle management of drug, medical device and other health products for Canada. RegulatoryServices Regulatory submissions and life cycle management of drug, medical device and other health products for Canada.Discover this service » Clinical TrialApplications Our team str...
Before medical device andin-vitrodiagnostic (IVD) device manufacturers can legally sell their products in Canada, they must comply with Health Canada's medical device regulations. However, it is important to know the correct medical device classification for your product before starting the registration...
Compliancewith local, regional or International Air Transport Association regulations. Special supportdepending on the duration, locations, sensitivity and volume of shipments. Insurance:extra financial protection based on the true value of the contents of your shipment. ...
Medical device firms must haveISO 13485 certificationfor their quality management systems. ISO 13485 certification is required for companies that design, manufacture, install, and service medical equipment and related services. When performing compliance evaluations, regulatory bodies and certifying organization...
Cosmereg regulatory affairs consultants assist clients to comply with the US FDA, Health Canada and EU regulations for cosmetics, food, medical devices and dietary supplements industries.
Foreign currency drafts are subject to sanctions compliance regulations and payee names are screened against persons listed under international sanctions. Depending on the result of that screening, a payee might not be able to cash a foreign currency draft. ...
ARS NETWORK is not “HIPAA compliant.” You are solely responsible for any required compliance with federal or state laws governing the privacy and security of personal data, including medical or other sensitive data. You acknowledge that the Services may not be appropriate for the storage or cont...