Twitter
//Quality

Quality Control & Regulatory Affairs


PHD Medical complies with the stringent, global medical device regulations required for the design, development, production, testing, distribution and installation of Televisit®, NPOSES and ETRENDING® medical device software and medical device systems; which are approved for sale in Canada, Mexico, the United States and the European Union.

PHD Medical has developed software, hardware, systems and services that are safe, secure, easy to use, and meet the needs of patients and healthcare practitioners. We utillize best practices in medical device quality assurance and regulatory affairs, to ensure the provision of safe, secure and effective medical devices for patients and health care users. We comply with the strict requirements of ISO-14971, the global standard for risk management for medical devices. We ensure data privacy, protection of personal health information and security using state-of-the-art tools and processes within healthcare environments to conform to regulatory requirements.

PHD Medical complies with international medical device regulatory standards including ISO-13485, ISO-9001, Canadian Medical Devices Regulations, the EU AIMDD/CE Marking and European MDD Directive 93/42/EEC (Annex II excluding Section 4) as well as the USA FDA 21 CFR Parts 820, 803 & 806 requirements and COFEPRIS medical device regulations from the Mexican Ministry of Health.

Medical Device Licenses

PHDMedical has the following medical device licenses.

NPOSES Medical Device Health Canada License #68463

Televisit Medical Device Health Canada License #69348

eTrending Medical Device Health Canada License #87942

NPOSES FDA 510(k) Pre-Market Notification #K060616

Televisit FDA 510(k) Pre-Market Notification #K062338

Quality Certificates

PHD Medical has the following Quality Certificates.

ISO 13485 CMDCAS

ISO 13485 UKAS

ISO 9001

CE Marking

European MDD Directive 93/42/EEC (Annex II excluding Section 4) for Televisit, NPOSES & Etrending Products