Comprehensive and Cost-Effective Medical Device Compliance
Nimonik supports the medical device sector with access to key industry standards as well as regulatory information and updates required to support product development, approval, and ongoing compliance activities.
Complete Medical Device Industry Standards Coverage
Medical device customers can obtain full coverage of their required industry standards by building custom subscription collections with Nimonik. Since Nimonik is an official distributor of ASTM International and 90+ SDOs, users can access ASTM standards alongside other standards in a single platform. No need to access ASTM Compass and jump between different platforms.
While accessing key documents, users can leverage powerful workflow tools and features to make the most of their standards. Nimonik’s platform includes free updates, document comparison tools, usage reports, audit features, and much more! Additionally, users can link standards with operational elements, enabling teams to proactively review changes and assign tasks to relevant team members.
Top Medical Device SDOs at Nimonik
Affordable Standards Access
Nimonik offers a cost-effective industry standards package for small and medium medical device companies looking to access essential ISO and IEC standards for the medical device industry, as well as core platform tools and features. Created for emerging medical device organizations around the world, the standards in this highly affordable offer are not site-restricted and are available in English, French, or German.
Essential Medical Device Standards Package
Access 27 of the most important EN-ISO and EN-IEC standards for Medical Device organizations in one budget-friendly collection. These essential standards are frequently referenced within regulatory frameworks and play an important role in product development, risk assessment, and regulatory submissions. Customers can add more standards to their subscription at any time to cover their additional requirements.
- Quality Management and Risk Management
- EN-ISO 13485 — Medical devices quality management systems
- EN-ISO 14971 — Application of risk management to medical devices
- EN-ISO 24971 — Guidance on the application of ISO 14971
- Biocompatibility
- EN-ISO 10993 Series — Biological evaluation of medical devices
- Includes EN-ISO 10993-1, EN-ISO 10993-5, and EN-ISO 10993-10
- Sterilization Processes
- EN-ISO 11135 — Ethylene oxide sterilization requirements
- EN-ISO 11137 Series — Sterilization of health care products
- Includes EN-ISO 11137-1, EN-ISO 11137-2, EN-ISO 11137-3, and EN-ISO 11137-4
- EN-ISO 11138-1 — Requirements for Biological Indicators
- Packaging and Controlled Environments
- EN-ISO 11607 Series — Packaging for terminally sterilized medical devices
- Includes EN-ISO 11607-1 and EN-ISO 11607-2
- EN-ISO 14644-1— Classification of air cleanliness in cleanrooms
- Labeling and Manufacturer Information
- EN-ISO 15223 Series — Symbols to be used with medical device labels
- Includes EN-ISO 15223-1 and EN-ISO 15223-2
- EN-ISO 20417 — Information supplied by the manufacturer
- Clinical Evidence
- EN-ISO 14155 — Good clinical practice
- Medical Electrical Equipment
- EN-IEC 60601 Series — Safety and performance of medical electrical equipment
- Includes EN-IEC 60601-1, EN-IEC 60601-1-2, EN-IEC 60601-1-8, EN-IEC 60601-1-11
- Medical Device Software and Usability
- EN-IEC 62304 — Medical device software lifecycle processes
- EN-IEC 62366 Series — Usability engineering for medical devices
- Includes EN-IEC 62366-1 and EN-IEC 62366-2
- EN-IEC 60601-1-6 — General requirements for basic safety and essential performance
Customer Reviews
I just want to say thank you for being so responsive to my requests for documents. You all are great and treat your customers the way I wish everyone did… and way beyond most customer service departments!
– Engineer at a Major Medical Device Company
I can’t begin to tell you how informative and helpful the Nimonik is…
– Technical Lead at Medical Device Company
Stay Ahead of Global Regulations with Real-Time Updates
Receive real-time regulatory updates for new and proposed regulations to ensure your company remains compliant across multiple markets; Nimonik has one of the most comprehensive regulatory databases with 600,000+ documents from 75 countries. Access the latest regulatory documents within the platform to eliminate the burden of manual tracking, accelerate market approvals, and reduce compliance risks associated with outdated or inconsistent information.
Speed up decisions with the help of AI-powered features, including AI-extended summaries and AI-enhanced clause texts to quickly understand essential requirements without reading the whole document. AI applicability analyses — to determine whether an obligation applies, may apply, or does not apply to that facility — is currently in beta-mode and will soon be live.
Teams can also leverage native workflow tools to extract specific clauses and transform them into actionable operational steps. By linking these obligations directly to risk assessments and audit templates, Nimonik helps medical device companies achieve compliance while freeing up their staff from document tracking and data entry.
Essential Medical Device Regulatory Packages
Nimonik provides highly affordable regulatory monitoring collections for 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.
Essential medical device regulatory packages are available for any of the three following jurisdictions:
Regulatory Framework: 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
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
Regulatory Framework: Canada
- Medical Devices Regulations (SOR/98-282) administered by Health Canada
- Supporting regulatory guidance documents
Bonus: International Guidance Documents
Each jurisdiction package also includes a bonus set of documents covering international regulatory guidance documents.
- 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
Empower your team to stay compliant and navigate complex approval processes with ease. By tracking regulatory updates, understanding market entry requirements, and assigning actionable tasks, medical device companies can accelerate time-to-market and respond faster to ever-changing requirements. Customers can add extra jurisdictions and topics to their subscription at any time to cover additional requirements.
Don’t see the regulatory content you need? Contact us to discuss additional options.
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.
