Compliance & security architecture.
MDR, GDPR, BSI, ISMS and audit prep, from a team that has passed real audits, not just talked about them.
Compliance & security architecture
In medical technology, energy and the Mittelstand, regulation often decides market access and liability. We translate requirements from MDR, GDPR and BSI into concrete architecture, documentation and processes, and support you through to a passed review. Our founder has owned systems that passed a pharma pentest with zero findings and several ISO 27001 audits.
- ✓Security architecture & threat analysis
- ✓ISMS setup
- ✓MDR & GDPR concepts
- ✓Risk analysis
- ✓Penetration-test preparation
- ✓Audit support
Security architecture & threat analysis
Documented risks, data flows and safeguards as a solid basis for any review.
ISMS to ISO 27001 / BSI
Building or hardening a management system with policies, roles and evidence.
MDR & GDPR concepts
Risk analysis, technical documentation and data-protection concepts for the conformity assessment.
Pentest preparation
Targeted hardening and evidence so external penetration tests bring no surprises.
Audit support
Preparation, dry runs and support through to a passed certification.
Gap analysis & roadmap
A clear view of open items and a prioritised path to compliance.
Proven, not claimed.
0 findings in a pharma pentest
A platform our founder built passed a global pharma company’s penetration test with zero findings.
BSI security architecture
Experience with security architecture to BSI Common Criteria and TR-03109, in direct exchange with the BSI.
ISO 27001 passed multiple times
We know audits from the inside and prepare you specifically for them.
From idea to audit.
Assessment
Where you stand, what the regulation requires.
Gap analysis
A clear view of gaps and risks.
Implementation
Concepts, documentation, hardening.
Audit
Support through to a passed review.
FAQ
Does Pyinv prepare for penetration tests?
Do you support MDR conformity?
Which standards do you cover?
Do you support us through to certification?
Also for existing systems?
How quickly are first results visible?
Facing an audit or certification?
We’ll get you through it safely. The intro call is free.
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