Regulatory consulting

Crafting the regulatory strategy, establishing Quality Management System, and driving your regulated product documentation and certification efforts.

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
  • ISO 42001
    ISO 42001
  • MDR
  • 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
  • CCPA

What we offer

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

Regulatory Strategy Definition
Regulatory strategy definition

Our unique workshop is designed to provide precise support in defining the Intended Purpose and devising an optimal regulatory strategy for your medical device.

QMS knowledge base
Ready-to-use QMS knowledge base

Offering document templates as a starting point for establishing a Quality Management System in your organization, ensuring compliance with major market regulators (i.e. Swissmedic, TGA, MHRA), and based on ISO 13485, ISO 14971, and IEC 62366.

Product compliance
Product compliance and documentation support

Our team offers a distinctive blend of refined regulatory expertise and comprehensive software knowledge, enabling us to assist you in documenting your product and simplifying your compliance journey (in the EU, US, AU, UK, CH).

Quality Manager as a Service
Quality manager as a service

Our regulatory experts, each boasting over a decade of experience, are ready to lead the QMS definition, implementation, training, certification and continuous improvement process.

Internal or supplier audits
Internal or supplier audits

Rely on our team of certified lead auditors for thorough gap assessments and QMS audits, whether for your current QMS or as a supplier control measure.

Quality and Regulatory Training
AI regulations

Elevate your team's proficiency in quality and regulatory matters with our training program. From audits to ISO 14971 risk management, ISO 13485, IEC 62304 requirements, AI regulations and more.

ISMS knowledge base
Ready-to-use ISMS knowledge base

Get a set of document templates to be used for establishing Information Security Management System in the organization compliant with ISO 27001:2022.

Information Security Officer as a Service
Information security officer as a service

Allow our seasoned team of regulatory experts, boasting over a decade of experience, to lead your ISMS definition, implementation, training, certification and continuous improvement processes.

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.”

Zoran Velkoski,Co-founder, gMendel®

“Overall, our collaboration with Star and Grzegorz, in particular, was exceptional. Star understood our needs quickly, enabling us to optimize our time. The team answered questions quickly, were incredibly flexible and created an excellent experience for our employees to work alongside. We are incredibly satisfied with Star and give the team our highest recommendations.”

Christian Lodberg Jensen,Product Manager, SelfBack

Starting as a young startup in the health industry, we found the EU regulations really tough. Getting our Quality Management System (QMS) going seemed almost impossible. That's when Star's team came in. They helped us set up our QMS quickly with easy-to-use templates that saved us a lot of time. The ins2outs system they introduced is simple and perfect for managing QMS tasks. Their help was a game-changer for us.

Daniel Otero Baguer,Co-founder & CEO, aisencia

Contact our experts

North America, Big

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

North America, Big

Star is a global technology consulting firm that seamlessly integrates strategy, design and engineering as an end-to-end partner on its clients’ digital journeys. Star’s unique approach helps rapidly expanding startups and established enterprises reach their endgames while prioritizing empathy for the end-users, society, and the planet.

Insights & inspiration

Receive the latest Star insights on trends, technologies and endgame-driven approaches straight to your inbox.


Or write us at

© Copyright Star 2024. All rights reserved Privacy Policy

plus iconminus iconarrow icon pointing rightarrow icon pointing rightarrow icon pointing downarrow icon pointing leftarrow icon pointing toparrow icon pointing top rightPlay iconarrow pointing right in a circleDownload iconResume iconCross iconActive Badge iconInactive Badge iconFocused Badge iconDropdown Arrow iconQuestion Mark iconFacebook logoLinkedin logoLinkedIn logoFacebook logoTwitter logoInstagram logo