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.
by Stefan Schlichting, David Box, Tomasz Puk
Podcast•HealthTech•
Why new patient data access laws equal new opportunities for medical product development
by Geoffrey Parker, Yanick Gaudet, Drew Hannah
We're certified and experienced healthcare technologists
Quality Management Standards
- ISO 13485
- ISO 14971
- MDR
- IVDR
- 21 CFR 820
- IEC 62304
- IEC 62366
Information Security
- ISO 27001
- IEC 22301
- ISO 27100
- ISO 27110
- GDPR
- CCPA
- HIPAA
Technologies
- ins2outs
- Security tests
- 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 certificationWe 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
serviceWe support your team with a specialist to supervise, manage, train and lead quality management activities in your organization.
Information security
officer as a serviceWe 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 activitiesWe 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
definitionWe 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
definitionWe 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 marketWe 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.”
Zoran Velkoski,Co-founder, gMendel®
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