Confidee / Compliance / Industries

Medical

Manufacturing PCBs for medical devices requires compliance with GMP, ISO 13485, and biocompatibility standards. Sterility, traceability, and documentation are critical to meet regulatory requirements and ensure patient safety.

Compliance Flow for Medical

When producing electronics within Medical, there are several attributes you need to consider. This is how our compliance flow contribute

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Cyber Security

Access Control

Role-based access, least privilege policies, single sign-on and enforced MFA to limit who can view or export sensitive design and compliance data.

Version Control

By maintaining rigorous version control, we can maintain compliance with industry standards and regulations, which often require the documentation of all product iterations.

Operational Control

Our operational control includes policies and procedures that protect sensitive information and maintain manufacturing integrity. By enforcing strict controls, we prevent unauthorized access to critical systems, reducing the risk of cyberattacks and data breaches

Non-repudiation Control

Our non-repudiation control is vital for ensuring accountability and protecting sensitive data. By implementing measures that confirm original actions and communications, we prevent any party from denying their involvement.

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Sourcing

Compliance Audit

It is a long established fact that a reader will be distracted by the readable content of a page

Process Audit

It is a long established fact that a reader will be distracted by the readable content of a page

Reliability Audit

It is a long established fact that a reader will be distracted by the readable content of a page. It is a long established fact that a reader will be distracted by the readable content of a page

Quality Audit

It is a long established fact that a reader will be distracted by the readable content of a page

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Export Control

End-Use(r) Screening

It is a long established fact that a reader will be distracted by the readable content of a page

Product Classification

It is a long established fact that a reader will be distracted by the readable content of a page

Export License

It is a long established fact that a reader will be distracted by the readable content of a page

License Management

It is a long established fact that a reader will be distracted by the readable content of a page

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Product Development

Design for Manufacture

It is a long established fact that a reader will be distracted by the readable content of a page

Dual Sourcing

It is a long established fact that a reader will be distracted by the readable content of a page. It is a long established fact that a reader will be distracted by the readable content of a page

Product Reliability

It is a long established fact that a reader will be distracted by the readable content of a page

Compliance Reporting

It is a long established fact that a reader will be distracted by the readable content of a page

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Member of

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Standards

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Company headquarter is situated in Norway, with branch offices strategically positioned in Australia, Sweden, Finland, France, Poland, Italy, Germany, Hong Kong and Denmark.

Confidee AS

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0254 Oslo
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inbox@confidee.com
VAT 929 538 366

Offices strategically placed in Europe and Asia – Handling clients worldwide

Defense

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