BIOREG can advise on the building of an effective quality system in compliance with ISO 13485 and 21 CFR 820. We can perform on-site internal audits or external audits at manufacturing sites.
What is ISO 13485?
ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).
Requirements of ISO 13485 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated.
What Are the Benefits of Being Certified to ISO 13485?
Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.
BIOREG can audit your current quality system and provide an ISO 13485 gap analysis. We can build a full ISO 13485-compliant quality system for you from scratch or we can write specific SOPs and other regulated documents. We can also help you to prepare for the ISO 13485 audit.
In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.
What is 21 CFR 820?
21 CFR is a quality system regulation which set for the current good manufacturing practice (CGMP) requirements for the final medical device products in US.
The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.
The requirements in this part are intended to ensure that finished medical devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act). If a manufacturer engages in only some operations subject to the requirements in this part, and not in others, that manufacturer need only comply with those requirements applicable to the operations in which it is engaged.
Quality support may be budgeted in a flexible manner which includes hourly, per-project or retainer options. Get in touch to find out more about the Quality Support we can provide!