In the dynamic field of medical device manufacturing, partnering with a knowledgeable and reliable expert is crucial for addressing industry shifts, cost pressures and rigorous regulatory requirements. Regulatory compliance is more than a market prerequisite, it is a strategic advantage. Our services enable you to adapt effectively, showcasing your products' dependability and setting you apart in the competitive landscape.
Boost credibility and build customer trust
We enable you to:
- Ensure product quality and consistency
- Streamline production and service processes
- Effectively manage risks with proven compliance strategies
- Save time, money and resources
- Expand market reach and access new opportunities
- Stay ahead in the ever-evolving regulatory climate
- Combat counterfeit products and enhance supply chain traceability
- Elevate patient safety and treatment outcomes
World-leading regulatory compliance services
As a world leader in assessment, auditing and certification, our global network of experts offers comprehensive support for regulations like the EU MDR (2017/745) and IVDR (2017/746). With specialists worldwide, we ensure your compliance with diverse international standards. Our services, spanning MDR and IVDR, CE marking, UKCA, ISO 13485 and MDSAP, are delivered by our EU Notified Bodies and UK Approved Body, ensuring robust, transparent assessments and a competitive edge through regulatory trust.
We are:
- An EU medical device Notified Body (NB), with NB status in Belgium (NB 1639) and Finland (NB 0598)
- A UK Approved Body
- An accredited ISO 13485 (medical devices – quality management systems) Certification Body
- A recognized Medical Device Single Audit Program (MDSAP) Auditing Organization
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Avenida da Namaacha, km 1.5, nº 8274,
Cidade de Maputo, 1116,
Maputo,
Mozambique