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Medical Devices Regulatory Compliance

Comply with medical device and in vitro diagnostic regulations to enhance product quality and safety, enter markets and, ultimately, improve patient treatment.

Why medical devices regulatory compliance?

When manufacturing medical devices, you need an experienced and trusted partner to meet the challenges of sweeping industry changes, rising prices and regulatory demands.

In addition to being a prerequisite to selling products, regulatory compliance is an asset for your company. Our services can help you to adapt to changing business environments while demonstrating your products’ reliability and resilience and distinguishing you from competitors.

Key benefits of regulatory compliance

It is a complex challenge to ensure that all relevant medical device regulations and legislation are met. Compliance can guide you in producing and distributing safe and effective products to:

  • Enhance your credibility, and increase customer trust and confidence
  • Assure quality and completeness
  • Validate the consistency of production or service
  • Improve processes and efficiencies
  • Manage risks and provide proof of due diligence and compliance
  • Save time and money
  • Create greater opportunities and increase market access
  • Gain a competitive advantage
  • Keep up with the constantly changing regulatory environment
  • Reduce the number of fake devices and improve supply chain traceability
  • Enhance patient safety and treatment

Why choose SGS for medical devices regulatory compliance?

From assessment and auditing to certification and training around the latest regulations, such as Medical Device Regulation (MDR 2017/745), our global network of experts can provide exactly what you need, when you need it.

Because regulations and standards differ across countries and industries, we have specialists across the world to help ensure your compliance. We can provide audits against recognized certification schemes in the EU, the US and around the globe.

Whether you are manufacturing MRI machines, intelligent software as a medical device, hip implants, pregnancy tests or thermometers, our assessments are robust and transparent, offering you not just assurance of safety and efficacy, but a competitive edge that comes from demonstrating regulatory trust.

We are:

  • An EU medical device Notified Body (NB), with NB status in Belgium (NB1639)
  • A UK Approved Body
  • An ISO 13485 (medical devices – quality management systems) Accreditation Body
  • A Medical Device Single Audit Program (MDSAP) Auditing Organization

This means that our services cover a multitude of areas, including:

  • EU Medical Device Regulation (MDR)
  • CE marking
  • UK Conformity Assessed (UKCA)
  • ISO 13485 (and other) assessment, auditing, certification and training
  • MDSAP services
  • The medical device supply chain

As an MDR-designated NB with existing approvals under UKCA, we are one of the few regulatory bodies that can provide medical device certification services across all of Europe, including the UK and Northern Ireland.

A dedicated EU MDR and IVDR Information Center

Access important documents to guide your MDR and In Vitro Diagnostic Regulation (IVDR) certification applications in our information center.

Impartial, professional, precise

Our assessments are impartial, professional and precise, and a well-known source of assurance across numerous industries and sectors. Our laboratories, respected for their quick turnaround testing, are available around the clock, across the world.

Fine-tune compliance controls

The number of rules and the need for operational clarity continue to rise. Therefore, we can help you to consolidate and fine-tune compliance controls. This assures that you meet all necessary governance requirements without pointlessly duplicating effort.

Maintain your position, policies and procedures

It is not enough to just have policies and procedures, regulatory compliance is an ongoing mission and must be reviewed regularly for you to stay current in an ever-changing regulatory landscape. We can support you every step of the way, with regular reviews, audits and more, so you can stay on top of whatever challenges the future brings.

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