Why are accreditations important for medical device companies?

Having accreditations are essential for medical device companies as they ensure quality, safety, regulatory compliance, and market credibility in a highly regulated industry.

Our accreditations promote a risk-based approach designed to minimise failures, protect patients, and demonstrate that a trusted third-party body has recognised OSKA operations as meeting these rigorous international standards.

OSKA is committed to ensuring we are proactively identifying and managing risks throughout our production and supply chain processes, underpinning our commitment to continuous quality improvement, reliability, and safety, fostering innovation both within our business, and on a global scale.

OSKA is pleased to have been awarded the following awards:

ISO 14001

An international standard requiring businesses to implement an Environmental Management System (EMS) to reduce their environmental impact.

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ISO 9001

An international standard defining the requirements for a Quality Management System (QMS).

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ISO 13485

A harmonised standard for Quality Management Systems (QMS) specific to the medical device industry. It focuses on patient safety.

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Green Mark

OSKA are Green Mark Level 1 certified.
The Green Mark provides an internationally recognised environmental certification for companies that want to assure their clients and employees that they are conducting business to recognised environmental standards.

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Cyber Essentials Plus

OSKA complies with the requirements of the Cyber Essentials Plus Scheme.

The Certificate certifies that OSKA is meeting the Cyber Essentials Plus implementation profile and thus that, at the time of testing, OSKA’s ICT defences were assessed as satisfactory against commodity based cyber attack.

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We embrace Extreme Ownership

At OSKA, Extreme Ownership is at the heart of everything we do. We hold ourselves fully accountable, and our certifications are testament to the trust placed in our products and services, as well as our commitment to operating at the highest possible standards in order to protect patients and other service users. Through self-reflection and rigorous audits and assessments, we ensure compliance and drive ongoing technology, innovation, growth and development.