Regulatory consulting
Crafting the regulatory strategy, establishing Quality Management System, and driving your regulated product documentation and certification efforts.
Navigate international compliance and information security to streamline your 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 14971
- ISO 42001
- MDR
- IVDR
- 21 CFR 820
- IEC 62304
- IEC 62366
- MDSAP
Information Security
- ISO 27001
- IEC 22301
- ISO 27100
- ISO 27110
- GDPR
- CCPA
- HIPAA
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
Our unique workshop is designed to provide precise support in defining the Intended Purpose and devising an optimal regulatory strategy for your medical device.
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 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
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
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.
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.
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
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 VelkoskiCo-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 JensenProduct 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 BaguerCo-founder & CEO, aisencia
“We’ve been incredibly pleased with the consultancy services from Star, especially how they’ve integrated our ins2out software to enhance our QMS management. Their team not only listened attentively but also adapted their approach to make full use of our existing systems. Their expertise in MDR regulations and understanding in setting up the required documentation through ins2out have been beyond beneficial.”
Mathias BangCPO & Co-founder, Injurymap
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