Regulatory Compliance

Strategize: Plan and prepare for compliance

Product design and compliance scoping
We design the optimal product architecture for an efficient path to market and maintainability, identify compliance requirements early and define the boundaries of the regulated product, ensuring adherence to relevant standards and regulations.

Regulatory strategy definition
We craft solid regulatory strategies for global market entry, specifically tailored to your product, ensuring alignment with industry standards and regulatory requirements like MDR, IVDR, FDA, the EU AI Act, and requirements across multiple jurisdictions.

Specialized training programs
Prepare your team with targeted training on complex regulatory frameworks, including AI regulations (ISO 42001, EU AI Act), HealthTech standards and regulations (ISO 13485, IEC 62304, MDSAP, MDR, IVDR, FDA, ASPISE), and data privacy laws (GDPR, HIPAA).

Implement: Build your product with confidence

Integrated compliance management
Create and implement quality and information security management systems with  ins2outs, our all-in-one ML-powered compliance management platform, featuring tailored know-how sets.

Tailored system integration
Leverage our ready-to-use knowledge base and consulting support to tailor the system to your organizational reality and needs, accelerating your team's adoption and cutting implementation time by up to 75%.

Technical documentation support
Use our compliance experts to create and maintain comprehensive, audit-ready documentation, facilitating smooth conformity assessments, compliance evaluations, and ongoing regulatory adherence.

Evolve: Grow and maintain compliance excellence

Automated post-market monitoring
Leverage automation to continuously monitor your product's compliance, ensuring that your product maintains market approval with minimal manual intervention, reducing compliance costs and risks.

New regulation gap assessments
Identify and close compliance gaps for new regulations as they emerge, ensuring your products stay market-ready and reducing the risk of non-compliance, delays, or costly rework, which can affect your market access and competitive edge.

New market entry support
Enter new markets efficiently and reach new customers faster with targeted compliance management support, addressing specific regulatory requirements to ensure quick adaptation, reduced delays, and sustained compliance.

MedTech & Digital Healthcare

We assist MedTech and digital health companies in meeting global compliance standards like ISO 13485 and market regulators (EU MDR/IVDR, FDA, TGA, MHRA, etc.), ensuring product safety and quality.

AI and Machine Learning

We help companies build AI management systems compliant with industry standards and regulations (ISO 42001, EU AI Act).

Automotive

Supporting OEMs and software suppliers in the automotive industry, including electric and autonomous vehicles, to ensure adherence to IATF 16949, ISO 21434, ASPICE, and ISO 26262 for safety and security.

Quality and Information Security for Tech Companies

We ensure tech companies comply with ISO 27001, SOC2, and GDPR for data privacy and security management and ISO 9001 for quality management system.