Everything you need to prepare your device for successful market entry.
Regulatory and quality requirements during product design and development can be demanding. We help define your regulatory pathway, clinical strategy, risk management activities, and reimbursement approach while preparing submission-ready technical documentation.
Artificial Intelligence (AI) is becoming an integral part of medical devices. AI-enabled medical devices (AIaMD) introduce additional cybersecurity, privacy, and software compliance requirements that must be addressed early.
Medical devices powered by electrical energy must comply with extensive regulatory requirements for safety and performance. Many of these obligations are based on the IEC 60601 family of standards.
Medical devices that directly or indirectly interact with patients must demonstrate biological safety. We help manufacturers meet ISO 10993 requirements through appropriate biocompatibility evaluations and testing.
Most medical devices require clinical evidence, whether generated through manufacturer studies or supported by published literature. Manufacturers must evaluate the State of the Art (SOTA) to determine the clinical evidence needed for market approval.
Management platforms such as Althea support quality, information security, and regulatory compliance across medical devices, AI technologies, and data privacy requirements.
Everything you need to maintain compliance throughout your product’s market lifecycle.
Everything you need to maintain compliance throughout your product’s market lifecycle.
Our MDIS platform helps economic operators manage regulatory obligations across the entire supply chain. It also supports automated registration activities within regulatory databases such as EUDAMED.
Entering new regulatory markets often requires registration in EUDAMED and other databases. We help simplify registration activities, address regulatory challenges, and support complete submission requirements.
Evaluate regulatory, quality, and operational readiness before key business decisions. We help identify compliance gaps, assess technical documentation, review regulatory status, and highlight potential risks associated with medical devices, software, and AI-enabled products.
Effective management systems depend on regular audits. Our services include internal audits, supplier audits, due diligence assessments, FDA mock audits, MDR/IVDR quality audits, ISO 13485, ISO/IEC 27001, NEN 7510-1 audits, and external certification support.
Regulatory and quality compliance continues after market approval. We support regulatory strategy, clinical planning, risk management, and technical documentation activities required throughout the post-market phase.
Our experienced team provides interim professionals for critical compliance functions, including Data Protection Officers (DPOs), Persons Responsible for Regulatory Compliance (PRRCs), and Quality, Regulatory, and Information Security specialists.
Cookies help us improve your experience on our website. By using our site, you consent to the use of cookies as described in this policy.
