ISO 13485 certified

Contract manufacturing services operated under ISO 13485 quality management systems for medical device production and compliance.

Full-service medical device manufacturing with ISO 13485 certification, MDR compliance, and cleanroom production ensuring regulatory traceability and quality assurance.

ISO 9001 certification audit and assessment service for medical device manufacturers and healthcare organizations. Accredited by national bodies and recognized as an EU Notified Body under MDR 2017/745, enabling certified compliance across global markets. Conducted by sector-experienced auditors across 60+ countries.

EN ISO 13485-certified contract manufacturing of medical devices from prototype to production, supporting both startups and established manufacturers.

ISO 9001, ISO 14001, and ISO 45001 management system certification and training services for medical device manufacturers and healthcare organizations. Enables compliance with international quality, environmental, and occupational health & safety standards. Includes third-party audits, certification, regulatory guidance, and professional training delivered by certified auditors across 100+ countries.

ISO 13485 certification validates that medical device manufacturers have established and maintain quality management systems compliant with international standards. This certification demonstrates organizational capability to design, produce, and deliver safe and effective medical devices. Essential for regulatory approval and market access across global healthcare markets.

Professional translation services specializing in medical device documentation, technical manuals, and regulatory content across 50 languages. ISO 13485 and ISO 17100 certified to ensure compliance and accuracy for medical device manufacturers and healthcare organizations. Supports multiple content management systems and technical formats for efficient localization of medical literature and collateral materials.

ISO 13485 certification service for medical device manufacturers ensuring compliance with international quality management standards. BSI provides accredited certification and auditing to establish safety, efficacy, and regulatory acceptance of medical devices across global markets.

ISO 13485:2016 certification validates that medical device manufacturers have established and maintain a compliant quality management system. This certification demonstrates adherence to international standards for design, production, installation, and servicing of medical devices, ensuring product safety and efficacy throughout the device lifecycle.

We can deliver consulting focussed on one or several areas of your Quality Management System; from Design Control to Post Market, including complaints and CAPA processes.

Comprehensive certification and auditing support for medical device manufacturers seeking ISO 13485, ISO 9001, and ISO 27000 compliance. Services include quality management system development, regulatory documentation, risk management, and design control to facilitate market introduction of medical devices globally.

Regulatory consulting service specializing in ISO 13485 certification and CE marking for medical devices. Supports diagnostic and therapeutic device manufacturers through compliance documentation, authorised representative services, and regulatory strategy across European markets. Fixed-price offerings provide cost transparency for device classification and market authorization.