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Life Science

Life. Is there anything more important than life, health and well-being? In life science, we are passionate about saving lives and making life easier for individuals as well as for humanity in general. Big words, but we stand by them.

It has been said that the first 200-year-old has already been born. This gives perspective. There are presently enormous opportunities for highly advanced healthcare for those with access. There are also major opportunities for improving the lives of everyone on our planet. We work with both perspectives.

Our focus on life science encompasses bioengineering, medical technology products and the pharmaceutical industry. We know the rules and regulatory requirements and how to effectively develop and bring products to market. In addition, we also deliver solutions for manufacturing products.

In life science, we have over 140 clients, from small startups to the truly big global companies. We have our own quality management system and in Stockholm and Uppsala we are ISO 13485 certified. And we have an excellent track record in developing prize-winning analysis instruments and medical technology equipment especially developed for our customers.

By combining knowledge and skills in different fields, innovative solutions to complex challenges are created. Technologies such as AI and Internet of Things have become increasingly important. This is due to the increased digitalization of healthcare and preventive care.

With our extensive experience, references, quality systems and certifications as well as reusable components and frameworks, we rarely start from scratch. We always have an edge and that benefits our clients.

Our services

  • Product development of medical devices (IVD, MD) according to your or Prevas' ISO13485 certified QMS.
  • Experts in
    QC, QA and RA
    Product development; systems, SW, electronics, testing, mechanics design and development
    Risk management, validation and verification
    Fluid and gas handling
  • Setup and improvement of QMS and eQMS
  • Regulatory services, such as consulting in IVDR & MDR, technical documentation, CE marking, FDA applications/registrations
  • Due diligence regarding regulatory and technical audits
  • Courses in Life Science, such as CE marking, development of medical technology software (ink apps), regulations and standards, QMS etc.

Organizations and partners

Swedish Medtech, SmiLe, UIC, Medeon Science Park, Medea, Apotekarsocieteten

Read more about our services.

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References

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