Are you correctly setting stakeholder expectations?

In a world of increasing healthcare expenses, the need for safe and effective medical device technology is greater than ever. All stakeholders, including patients, regulators and manufacturers, benefit from innovation and access to the most effective solutions for clinical needs.

Ensuring that all new technology meets regulatory requirements is critical and absolutely expected for all new devices.

Setting incorrect expectations in the regulatory clearance process, such as CE Marking for the European market, can lead to delays that have far reaching consequences for all stakeholders.

Incorrect expectations can:

  • Hold up benefits to patients, clinicians, healthcare providers and payers
  • Restrict the access to the most effective technologies
  • Impact investment needed to achieve commercialization of new devices
  • Damage confidence in manufacturers
  • Disappoint stakeholders requirements 


What medical device manufacturers need

Medical device manufacturers are focused on bringing innovative yet safe products to patients worldwide. Manufacturers need predictability and transparency during the regulatory process from product development, through clinical investigation to product clearance and market launch. The speed and reliability of the certification process is key to setting correct stakeholder expectations and avoiding unnecessary surprises.

What to look for in a certification body

Medical device manufacturers looking to certify for CE Marking and/or management system standards, such as ISO13485, should seek a focused medical device certification body that has sufficient professional resources to deliver to expectations including:

  • Quality Management System Assessors with vast experience in the medical device industry, who undergo ongoing training to maintain strong current credentials 
  • Product Experts who thoroughly understand the medical device technology that they review from years of hands-on design, development and clinical experience
  • Microbiologists to ensure confidence in controlled environments and sterilization, which if not done effectively, places patient safety in significant jeopardy

Manufacturers need a highly competent, customer-focused certification/notified body that understands the challenges of the regulatory and quality environment, and always in tune with state of the art.

Solutions and services that we provide

BSI’s mission is to ensure patient safety while supporting timely access to global medical device technology. We strive to set the global standard in thorough, responsive, predictable conformity assessments, evaluations, and certifications.

CE Marking logo

BSI is a leading provider of CE marking services, enabling medical device manufacturers to qualify their product for the European Union market access.

ISO 13485 icon

BSI certifies organizations to ISO 13485, which addresses quality management systems, and ISO 14971, which addresses risk management systems, for medical device manufacturers.

Checklist icon

BSI is fully supporting the Medical Device Single Audit Program (MDSAP) pilot, to combine multiple regulatory audits, and is working to achieve designation as a fully qualified MDSAP Auditing Organization.

BSI Action Manager iconOur BSI Action Manager software tool, powered by BSI Entropy, helps organizations effectively manage corrective and preventative actions related with audits, non-conformities, and incidents.

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BSI Compliance Navigator makes it easy for medical device manufacturers to maintain and trace the standards their products and processes need to meet to be compliant.

Training programs iconWe train over 90,000 people per year across the globe.  Our medical device training programs are led by technical experts with in-depth experience in the field.