Regulatory-consulting

Regulatory consulting

We help you craft the healthcare regulatory strategy to get your medical device on the market — and then design, develop and support you throughout the entire product lifecycle.

Helping healthcare innovators and digital service providers navigate international compliance and information security to streamline their path to market

Meet regulatory and information security requirements, prepare your solutions for the entire product lifecycle, build and evolve remarkable MedTech and digital healthcare products.

We're certified and experienced healthcare technologists

Quality Management Standards

  • ISO 13485
    ISO 13485
  • ISO 14971
    ISO 14971
  • MDR
    MDR
  • IVDR
    IVDR
  • 21 CFR 820
    21 CFR 820
  • IEC 62304
    IEC 62304
  • IEC 62366
    IEC 62366

Information Security

  • ISO 27001
    ISO 27001
  • IEC 22301
    IEC 22301
  • ISO 27100
    ISO 27100
  • ISO 27110
    ISO 27110
  • GDPR
    GDPR
  • CCPA
    CCPA
  • HIPAA
    HIPAA

Technologies

  • ins2outs
    ins2outs
  • Security tests
    Security tests
  • Technical audits
    Technical audits

What we offer

We define quality and information security management systems and guide our clients from market placement through post-market surveillance.

  • QMS definition
    and certification

    We provide ISO13485, ISO14971, IVDR and other know-how sets through our ins2outs platform for the complete definition and build of quality management systems for medical devices including human factors design and IEC 62366.

  • Definition and
    certification of the
    information security
    management system
    (ISMS)

    We provide ISO 27001 and 27100, GDPR, CCPA and other knowhow sets through our Ins2Outs platform for the complete definition and build of information management systems for digital medical and healthcare products.

  • Quality manager as a
    service

    We support your team with a specialist to supervise, manage, train and lead quality management activities in your organization.

  • Information security
    officer as a service

    We support your team with an information security specialist to supervise, manage, train and lead to ensure all necessary organizational security measures are in place.

  • Managing product
    lifecycle activities

    We enable the design, development and release of regulated MedTech and digital healthcare products and accelerate market launch, including preparation of technical documentation and leading the conformity assessment process.

  • Privacy compliance
    definition

    We offer audits for compliance with GDPR, HIPAA, CCPA and other regulations and define your roadmap to achieve full compliance for a given privacy regulation.

  • Intended purpose and
    regulatory strategy
    definition

    We help you define your intended use statement, pursue the right classification and fulfill high-level product requirements and standards, including MDR, IVDR, FDA, 21 CFR 820, ISO 13485, ISO 14971, GDPR and HIPAA to launch new solutions and evolve legacy products.

  • Placing digital services
    on the EU market

    We enable foreign companies to start providing digital services within the EU regulatory framework.

Our clients say...

  • “Time-to-market is one of the decisive factors for any startup. Star’s team and their complete QMS offering, including QMaaS, gave us
    a huge head start on our quality and regulatory compliance. The success gMendel has experienced would not be possible without
    Star's contribution.”
    gMendel

    Zoran Velkoski,Co-founder, gMendel®

Contact our experts

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North America, Big

We are truly global.
Explore our locations around the world.

North America, Big

Star is a global team of product creators. We connect strategy, design and engineering services into a seamless workflow devised to build solutions with the right focus on impact, scalability, performance and prudence.

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Contacts

Or write us at hellostar@star.global

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