Group items tagged

Medical device and IVD equipment manufacturers mostly operate within the boundaries of a quality system, which complies with one or more of the international harmonized standards. Those systems are subjected to audits as part of the certification process and regulatory compliance. Internal audits performed by external bodies are a great way to control and maintain QMS activities.

Arazy Group provide online and/or onsite assistance in preparation of any third party audits and our consultant can escort you at the time of the audit.

Registration renewal is very important to maintain your product sales clearance and registration for as many years as possible. Renewal of product registration is mandatory in many markets and is subjected to a variety of requirements dictated by local authorities.

Foreign and local medical device manufacturers are now required to be inspected and be in compliance with the Brazilian Good Manufacturing Practices requirements prior to the submission of their devices for registration with ANVISA, the Brazilian authority in charge of the medical devices and IVDs clearance.

GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Many countries have enacted that pharmaceutical and medical device companies must follow GMP procedures and have their own criteria that correspond with their legislations.

Arazy Group team of experienced clinical and regulatory professionals can assist you in developing a comprehensive clinical development strategy for your device at every stage of product development.

Arazy Group is a leading global name in medical device consultancy offering a wide range of medical device regulatory services and clinical literature review for medical device manufacturers and distributors in the region.

Arazy Group provide training, step by step guidance, external auditing and online consulting. Also, we fully outsource quality assurance maintenance services for your organization.

for any assistance you may need for the preparation or implementation of GMPs. We also provide step by step guidance, external auditing, online consulting and fully outsourced quality assurance maintenance services for your organization.