Third-party ISO 13485 certification from an IAS-accredited certification body, within our accredited scope. Prove your device quality management system to customers, partners, and regulators.
ISO 13485:2016 is the international standard for quality management systems in the medical device industry. It extends quality management to the requirements that matter for devices: design controls, risk management, traceability, sterile processes where applicable, and rigorous documentation.
Certification means an accredited, independent certification body has audited your QMS in operation and confirmed it conforms to the standard. Device makers require it of suppliers, and regulators worldwide build on it.
OEMs routinely require ISO 13485 from component makers, contract manufacturers, and service providers before they will qualify you.
Regulatory frameworks worldwide build on ISO 13485, so a certified QMS puts your documentation in the shape reviewers expect.
Design controls, traceability, and CAPA discipline reduce field failures and recalls.
GMCS runs a defined, two-stage certification audit. You always know where you are in the process and what comes next.
There is no one-size price. Your quote is scoped from audit time, which is driven by four factors. Organizations with fewer than 100 employees qualify for the GMCS Small Organization Program's discounted pricing.
Get a Scoped QuoteIf your current certification body is slow to schedule, slow to answer, or priced for someone else's overhead, transfer your accredited certificate to GMCS. Your certification cycle and surveillance schedule continue uninterrupted, and in most cases there is no repeat of Stage 1 and Stage 2.
Start a TransferTell us your organization size, sites, and timeline. We'll scope the audit program and send a proposal, with no consulting upsell.
Request a Certification QuoteGMCS certificates carry accredited, internationally recognized status. Verify our accreditation and any certificate we issue.
