Medical device manufacturers operate in a complex regulatory environment where product design, manufacturing processes, and post-market activities are governed by a combination of regulations, technical standards, and regulatory guidance documents. Managing these requirements across multiple jurisdictions can be challenging, particularly for organizations marketing products in several global markets.
Nimonik supports the medical device sector with:
- access to key international engineering standards
- regulatory information and updates required to support product development, approval, and ongoing compliance activities
Access to Key Medical Device Industry Standards
By using the Nimonik platform, organizations can access and monitor key engineering standards commonly used in the medical device industry, including standards supporting quality management systems, risk management, product safety, software development, labeling, and biocompatibility.
Examples of widely used standards include:
Quality Management & Risk Management
- ISO 13485 — Medical devices quality management systems
- ISO 14971 — Application of risk management to medical devices
Medical Electrical Equipment
- IEC 60601-1 — Safety of medical electrical equipment
- IEC 60601-1-2 — Electromagnetic compatibility requirements
Medical Device Software
- IEC 62304 — Medical device software lifecycle processes
- IEC 62366 — Usability engineering for medical devices
Biocompatibility
- ISO 10993 series — Biological evaluation of medical devices
Labeling and Information
- ISO 15223-1 — Symbols to be used with medical device labels
- ISO 20417 — Information supplied by the manufacturer
These standards are frequently referenced within regulatory frameworks and play an important role in product development, risk assessment, and regulatory submissions.
Access to Major Medical Device Regulatory Frameworks
In addition to standards access, Nimonik provides regulatory monitoring capabilities covering major medical device regulatory frameworks. Regulatory packages can be configured based on the jurisdictions where an organization operates, allowing companies to focus on the regulatory requirements most relevant to their markets.
Typical regulatory coverage may include:
European Union
- EU Medical Devices Regulation (MDR – Regulation (EU) 2017/745)
- EU In Vitro Diagnostic Regulation (IVDR – Regulation (EU) 2017/746)
- MDCG guidance documents supporting the implementation of the European regulatory framework
United States
- FDA medical device regulations (21 CFR Parts 800–898)
- Relevant FDA guidance documents addressing topics such as device safety, clinical evaluation, and post-market obligations
Canada
- Medical Devices Regulations (SOR/98-282) administered by Health Canada
- Supporting regulatory guidance documents
International Guidance
- IMDRF (International Medical Device Regulators Forum) guidance documents, which support regulatory convergence and international best practices for medical device regulation
- Legacy GHTF guidance documents that continue to inform global regulatory approaches
By bringing together engineering standards, regulations, and regulatory guidance within a single platform, Nimonik enables organizations to centralize the monitoring of regulatory developments while maintaining access to the technical standards that support compliance and product development.
This approach allows regulatory affairs, quality assurance, and engineering teams to work within a single environment to track regulatory requirements, access relevant standards, and manage compliance activities across multiple jurisdictions.
Your Medical Device Requirements Starts Here
Access, manage, and monitor the regulations and industry standards that your operations rely on. Connect with an expert to streamline your standards management and ensure consistent, up-to-date access across your organization.
