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Medical devices are divided into class I, IIa, IIb and III. IVDs are divided into four categories: General IVDs, self-diagnostics, list A and list B. All medical devices exempt class I and General IVDs require the involvement of a Notified Body and the implementation of a quality management system, usually in line with ISO 13485.

Arazy Group is a major global medical device consultant serving a number of medical developers and manufacturers by providing them with professional and specific knowledge and consulting services in launching their products at a global level.

Biocompatibility can be a complex process as many medical devices are made of more than one material. The current leading standard for biological evaluation of medical devices is ISO 10993 at its latest version.

As an international company, we make sure we are available to our clients around the clock through various channels of communication in multiple languages.

The Clinical Research Administrator facilitates the timely execution and completion of high-quality clinical research by assisting investigators and industry sponsors with all aspects of the clinical research.

Arazy Group - Preparation of a regulatory dossier for the authorities can be cumbersome as It may contain tens of different documents, templates, reports, charts and graphics.

Arazy Group helps you with our expert CE Mark Consultancy services that offer verification, validation and product certification for medical devices, IVDs and equipment in Czech Republic. We also offer clinical trial monitoring and data management for you.

Arazy Group is a leading medical device consultant that provides medical device manufacturers with international acceptance, right product validation, medical device registration, product regulatory and marketing approvals to help them gain market approval for their medical devices and equipment.

European Union (EU) Authorized Representative, USA Designated agent, China after Sales service, Central & South American registrations holding companies, Japan MAH - Marketing Authorized Holder, Product Sponsor and similar entities are the legal and regulatory bodies a medical device manufacturer needs to source, appoint, contract, pay for and renew annually in order to fully satisfy the product sales clearance requirements.

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 help you with our expert CE Mark Consultancy services that offer verification, validation and product certification for medical devices, IVDs and equipment in Czech Republic. We also offer clinical trial monitoring and data management for you. You can gain from our numerous medical device regulatory and CE marking consulting services.

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