Efficient regulatory compliance for AI innovators

Navigating AI regulations made easier. Benefit from our specialized expertise to ensure your business meets industry standards and achieves a swift market presence.

Get in touch

AI regulatory roadmap
with Star

1

Define AI's intended purpose

Establish a clear and precise intended purpose for your AI product, laying the foundational groundwork for compliance throughout its lifecycle.
2

Classify product risk

Evaluate and categorize your AI product’s risk level based on its defined intended purpose, ensuring alignment with regulatory requirements.
3

Strategize regulatory path

Develop a comprehensive regulatory strategy, outlining the roadmap to market and identifying necessary compliance milestones for your AI product.
4

Establish Quality Management System (QMS)

Implement a robust QMS that adheres to all relevant and upcoming market regulations and standards (like the AI Act and ISO 42001) in Europe, US, UK, Australia, Canada, and beyond.
5

Implement QMS

Facilitate the adoption of the QMS within your organization, fostering awareness and ensuring its functionality and effectiveness.
6

Initiate notified body engagement

Establish communication and coordinate with the notified body to initiate the conformity assessment procedure, a crucial step for market access.
7

Undergo certification audits

Successfully navigate through third-party audits conducted by the notified body, aiming for QMS and product certification.
8

Maintain post-market oversight

Implement and adhere to a rigorous post-market surveillance and vigilance system, ensuring ongoing compliance and product safety after market launch.
9

Ensure continuous QMS advancement

Maintain the efficiency of your QMS, ensuring its ongoing development and timely updates to comply with the ever-changing regulatory requirements.
1

Define AI's intended purpose

Establish a clear and precise intended purpose for your AI product, laying the foundational groundwork for compliance throughout its lifecycle.
2

Classify product risk

Evaluate and categorize your AI product’s risk level based on its defined intended purpose, ensuring alignment with regulatory requirements.
3

Strategize regulatory path

Develop a comprehensive regulatory strategy, outlining the roadmap to market and identifying necessary compliance milestones for your AI product.
4

Establish Quality Management System (QMS)

Implement a robust QMS that adheres to all relevant and upcoming market regulations and standards (like the AI Act and ISO 42001) in Europe, US, UK, Australia, Canada, and beyond.
5

Implement QMS

Facilitate the adoption of the QMS within your organization, fostering awareness and ensuring its functionality and effectiveness.
6

Initiate notified body engagement

Establish communication and coordinate with the notified body to initiate the conformity assessment procedure, a crucial step for market access.
7

Undergo certification audits

Successfully navigate through third-party audits conducted by the notified body, aiming for QMS and product certification.
8

Maintain post-market oversight

Implement and adhere to a rigorous post-market surveillance and vigilance system, ensuring ongoing compliance and product safety after market launch.
9

Ensure continuous QMS advancement

Maintain the efficiency of your QMS, ensuring its ongoing development and timely updates to comply with the ever-changing regulatory requirements.

Star's three-dimensional approach:
expertise in action

Get a streamlined, actionable, and proven approach to regulatory challenges by leveraging our advanced product solution, in-depth industry knowledge, and practical services.

ins2outs: Compliance Management System

Leverage ins2Outs, our SaaS platform, to simplify the management of quality, information security, and privacy systems, ensuring your organization meets all required standards efficiently.

Knowledge Bases for QMS and ISMS

Access our comprehensive repository of policies, processes, regulations and standards, and document templates like ISO 42001, 13485, 27001, and 9001 crafted to assist you in achieving certification and maintaining regulatory compliance.

Regulatory and Quality Consulting

Benefit from Star’s expert guidance for a seamless regulatory journey, customized to your target markets. Our experienced regulatory team provides proficient assistance in developing, certifying, and optimizing your management systems, securing your products' readiness for market launch.

Optimize your journey withcustom regulatory services

Every business has unique challenges and goals. Our tailored regulatory services align with your specific needs, ensuring you move forward with confidence and clarity.

Ins2outs: Compliance ManagementSystem

Leverage Ins2Outs, our SaaS platform, to simplify the management of quality, information security, and privacy systems, ensuring your organization meets all required standards efficiently.

Knowledge Bases for QMS and ISMS

Access our comprehensive repository of policies, processes, regulations and standards, and document templates like ISO 42001, 13485, 27001, and 9001 crafted to assist you in achieving certification and maintaining regulatory compliance.

Regulatory and Quality Consulting

Benefit from Star’s expert guidance for a seamless regulatory journey, customized to your target markets. Our experienced regulatory team provides proficient assistance in developing, certifying, and optimizing your management systems, securing your products' readiness for market launch.

Optimize your journey with
custom regulatory services

Every business has unique challenges and goals. Our tailored regulatory services align with your specific needs, ensuring you move forward with confidence and clarity.

Regulatory strategy

Custom strategies designed to expedite your product's market entry

Quality management

Tailored systems to ensure your operations align with industry standards

Technical documentation

Comprehensive and compliant documentation crafted to suit your product specifics

Regulatory training

Training modules structured around your team's expertise and knowledge gaps

Conducting audits

 Personalized audit solutions that address your unique business structure and requirements

InfoSec management

Customized strategies to protect your data and maintain regulatory compliance

Navigate AI
compliance
confidently
with Star

From startups to enterprises:
proven track record in navigating
regulatory challenges

Lacking a comprehensive Quality Management system?

Star empowers your business to establish a robust and compliant QMS, aligned with all vital software-relevant standards and guidelines across major markets.

Need a bootcamp to understand AI regulations?

Transition smoothly with Star, as we guide you through the nuances of new and constantly evolving regulatory landscapes.

Need to ensure AI product compliance?

Leverage our regulatory expertise to establish processes that adhere to pertinent regulations, guidelines, and standards, guaranteeing your product's compliant development

Don’t need a full-time QM/ISO as a small organization?

We offer flexible engagements tailored to your needs, ensuring compliance without unnecessary overhead.

Searching for the optimal regulatory strategy?

Rely on Star team to develop a comprehensive regulatory plan to expedite your product's time to market and optimize your budget.

Looking to document your AI product?

Rely on our regulatory experts to assist in generating technical documentation that adheres to ISO and other prevalent industry standards for your product.

Stuck with old-school QMS systems?

Star modernizes your approach, streamlining and optimizing your QMS for the digital era, introducing automation for routine tasks and freeing up your time for impactful work.

Need technical documentation enhancement?

Our experts craft comprehensive documentation that aligns with regulatory standards, ensuring your submissions are seamless.

R&D departments need support in validating technical decisions from a regulatory standpoint?

Our experts seamlessly collaborate with your R&D team, employing 'safe by design' and 'privacy by design' best practices while validating technical decisionsto ensure compliance from conception to completion.

Need to build QMS awareness in the team?

With our specialized training modules, your team will be equipped to operate efficiently within an QMS framework.

Updating your existing QMS to a new regulation/standard?

Stay ahead of the curve with Star. We ensure your QMS evolves with changing regulations, maintaining your product's market relevance.

Require assistance with QMS or product documentation audits?

Choose Star for a comprehensive assessment of your QMS and product documentation, coupled with tailored training to boost your team's internal audit proficiency.

Lacking a comprehensive Quality Management system?

Star empowers your business to establish a robust and compliant QMS, aligned with all vital software-relevant standards and guidelines across major markets.

Need a bootcamp to understand AI regulations?

Transition smoothly with Star, as we guide you through the nuances of new and constantly evolving regulatory landscapes.

Need to ensure AI product compliance?

Leverage our regulatory expertise to establish processes that adhere to pertinent regulations, guidelines, and standards, guaranteeing your product's compliant development.

Don’t need a full-time QM/ISO as a small organization?

We offer flexible engagements tailored to your needs, ensuring compliance without unnecessary overhead.

Searching for the optimal regulatory strategy?

Rely on Star team to develop a comprehensive regulatory plan to expedite your product's time to market and optimize your budget.

Looking to document your AI product?

Rely on our regulatory experts to assist in generating technical documentation that adheres to ISO and other prevalent industry standards for your product.

Stuck with old-school QMS systems?

Star modernizes your approach, streamlining and optimizing your QMS for the digital era, introducing automation for routine tasks and freeing up your time for impactful work.

Need technical documentation enhancement?

Our experts craft comprehensive documentation that aligns with regulatory standards, ensuring your submissions are seamless.

R&D departments need support in validating technical decisions from a regulatory standpoint?

Our experts seamlessly collaborate with your R&D team, employing 'safe by design' and 'privacy by design' best practices while validating technical decisions to ensure compliance from conception to completion.

Need to build QMS awareness in the team?

With our specialized training modules, your team will be equipped to operate efficiently within an QMS framework.

Updating your existing QMS to a new regulation/standard?

Stay ahead of the curve with Star. We ensure your QMS evolves with changing regulations, maintaining your product's market relevance.

Require assistance with QMS or product documentation audits?

Choose Star for a comprehensive assessment of your QMS and product documentation, coupled with tailored training to boost your team's internal audit proficiency.