
by Christopher Scales, Geoffrey Parker
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.
Meet regulatory and information security requirements, prepare your solutions for the entire product lifecycle, build and evolve remarkable MedTech and digital healthcare products.
We define quality and information security management systems and guide our clients from market placement through post-market surveillance.
We 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.
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.
We support your team with a specialist to supervise, manage, train and lead quality management activities in your organization.
We support your team with an information security specialist to supervise, manage, train and lead to ensure all necessary organizational security measures are in place.
We 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.
We offer audits for compliance with GDPR, HIPAA, CCPA and other regulations and define your roadmap to achieve full compliance for a given privacy regulation.
We 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.
We enable foreign companies to start providing digital services within the EU regulatory framework.
We are truly global.
Explore our locations around the world.