Knowledge Hub

The medical device world spans many regulatory concepts and standards—we have hands-on experience with most of them. Explore our guides below and reach out anytime to learn more.

Medical Device & SaMD rådgivning emnebank

How do we get started with a SaMD project?

Purpose: To establish a clear clinical purpose, regulatory roadmap, and cross-functional foundation before coding a Software as a Medical Device (SaMD) solution.

Focus: Early alignment of medical claims, MDR/FDA classification, patient data security, agile iterations, verification/validation, and traceable documentation.

Application: Startups, clinicians, and software teams developing medical apps, diagnostic software, or digital health solutions for regulated markets.

How do we get started with a Medical Device product?

Purpose: To turn a clinical idea or engineering concept into a safe, compliant, and commercially successful medical device through a structured 10-step roadmap.

Focus: Concept definition, market and regulatory strategy, cross-functional teams, prototyping, hardware/software engineering, verification/validation, and PMS.

Application: MedTech startups, hospital spin-outs, and established manufacturers bringing new physical or connected medical devices to the EU or US market.

What is MDR (Medical Device Regulation)?

Purpose: EU MDR (2017/745) is the European regulation governing the safety, clinical performance, traceability, and market surveillance of medical devices.

Focus: Clinical evaluation, Technical Documentation (Annex II & III), ISO 13485 QMS, risk management, UDI traceability, and Post-Market Surveillance.

Application: Mandatory for all manufacturers, importers, and distributors placing physical medical devices or SaMD on the European Union / EEA market.

What is ISO 13485?

Purpose: ISO 13485 is the internationally harmonized standard specifying Quality Management System (QMS) requirements for medical device organizations.

Focus: Establishing, implementing, and maintaining effective Design Controls, risk-based processes, traceability, supplier controls, and CAPA.

Application: Applicable to medical device and SaMD manufacturers, design houses, and critical suppliers seeking EU MDR, IVDR, MDSAP, or FDA QMSR compliance.

What is IEC 62304?

Purpose: IEC 62304 specifies international lifecycle requirements for the development and maintenance of medical device software (both SaMD and SiMD).

Focus: Software safety classification (Class A, B, C), requirements engineering, architecture, SOUP management, verification, configuration control, and problem resolution.

Application: Essential for manufacturers developing standalone medical software (SaMD) or embedded firmware/software in medical devices for EU MDR and FDA approval.

What is Risk Management?

Purpose: Medical device Risk Management (ISO 14971) systematically identifies, evaluates, controls, and monitors hazards to safeguard patients and users.

Focus: Lifecycle hazard analysis, risk estimation, inherent safety by design, verification of risk controls, benefit-risk analysis, and post-market feedback.

Application: Mandatory across all medical devices, IVDs, and SaMD products under EU MDR, IVDR, and FDA regulations.

What is a QMS?

Purpose: A Quality Management System (QMS) provides the structured processes and governance required to design, release, and maintain safe, compliant medical devices.

Focus: Document control, Design Controls, risk management, supplier qualification, CAPA, training, and Post-Market Surveillance aligned with ISO 13485 and MDR.

Application: Required for all medical device and SaMD manufacturers—tailored to fit lean startups as well as established MedTech organizations.

Cybersecurity Requirements for Medical Devices and SaMD

Purpose: To protect connected medical devices, SaMD platforms, clinical workflows, and patient data against cyber threats across the entire product lifecycle.

Focus: Threat modeling, secure-by-design architecture, encryption, access control, SBOM management, and vulnerability monitoring aligned with MDR, MDCG 2019-16, IEC 81001-5-1, ISO 27001, and FDA guidance.

Application: Essential for all networked medical devices, mobile medical apps, cloud-connected SaMD, and IoT healthcare solutions.

What is a PRRC?

Purpose: A PRRC (Person Responsible for Regulatory Compliance) is a legally mandated role for medical device and IVD manufacturers under EU MDR and IVDR Article 15.

Focus: Verifying device conformity prior to release, ensuring Technical Documentation and EU Declarations of Conformity stay up to date, and overseeing post-market surveillance and vigilance reporting.

Application: All EU MDR/IVDR manufacturers—including micro and small enterprises outsourcing the PRRC role to qualified external specialists.

How do we get AI approved in our medical product?

Purpose: To give MedTech and Digital Health companies a clear regulatory pathway for approving Artificial Intelligence (AI) and Machine Learning (ML) in medical devices and SaMD.

Focus: Documenting dataset quality, bias mitigation, performance validation, clinical utility, explainability, cybersecurity, and post-market algorithm monitoring under MDR, IVDR, EU AI Act, and FDA.

Application: Regulatory strategy, gap analysis, risk management, validation protocols, and Technical File preparation for Notified Body review.

How does a medical product achieve CE approval?

Purpose: To achieve mandatory European CE marking proving that a medical device or SaMD meets all safety, health, and clinical performance requirements under MDR or IVDR.

Focus: Step-by-step execution across preclinical testing, Technical File compilation, Clinical Evaluation (CER), Notified Body audits, and Post-Market Surveillance.

Application: Manufacturers bringing physical medical devices, SaMD, or IVDs onto the European market.

What is a Technical File (Technical Documentation)?

Purpose: A Technical File (Technical Documentation) is the mandatory regulatory dossier proving that a medical device or SaMD fulfills all safety and performance requirements under EU MDR or IVDR prior to CE marking.

Focus: Structured, traceable documentation of device description, GSPR checklist, ISO 14971 risk management, Design Controls, IEC 62304 software lifecycle, V&V, Clinical Evaluation (CER), and PMS (MDR Annex II & III).

Application: Mandatory for all medical device and SaMD manufacturers obtaining and maintaining CE marking in the EU—both Class I self-certified devices and Class IIa/IIb/III Notified Body submissions.

IEC 62304 Compliance Consulting

Purpose: Hands-on consulting to align your software engineering processes and documentation efficiently with IEC 62304.

Focus: Gap analysis, compliance strategy, agile process integration, software risk management, audit preparation, and developer training.

Application: MedTech and SaMD engineering teams seeking pragmatic IEC 62304 compliance without sacrificing development velocity.