Following Accuris’s announcement to end their partnership with ASTM International, Nimonik is now the leading standards management platform that allows users to access all of their ASTM standards, non-ASTM standards, and additional documents in one easy place. Many other providers don’t fully integrate ASTM standards into their platforms, often redirecting users to ASTM Compass.
Why Nimonik Is a Popular Choice for the Medical Device Industry
Nimonik and ASTM International announced a renewed agreement to offer ASTM standards to organizations around the world through Nimonik’s compliance management software. As a result, medical device companies don’t require a split solution and can access all of their industry standards in one easy place.
Nimonik’s platform provides access to one of the largest collections of standards and regulations in the world. Built for organizations that rely on a broad range of industry documents, their workflow tools excel at turning obligations (standards, regulations, permits, corporate requirements, etc.) into actions, audits, risk assessments, and more. Additionally, usage reports and other budget-friendly tools help departments manage costs easily. Most notably for standards users, organizations can access and manage industry documents from 90+ SDOs — including ASTM, ISO, ASCE, CSA, IEEE, API, IPC, and BSI — in one easy location, rather than hopping between platforms.
Medical Devices Regulatory & Standards Package
By bringing together engineering standards, regulations, and regulatory guidance within a single platform, Nimonik enables medical device 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.
Servicing the Medical Device Industry
Nimonik serves many of the top medical device companies around the world. Below are the industry standards that they use the most.
- ASTM F1980 — Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
- ASTM F88/F88M — Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F1929 — Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ASTM F136 — Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
- ASTM F138 — Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
- ASTM F75 — Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants
- ASTM F382 — Standard Specification and Test Method for Metallic Bone Plates
- ASTM F2077 — Standard Test Methods for Interbody Fusion Devices
- ASTM F2503 — Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
- ASTM F2100 — Standard Specification for Performance of Materials Used in Medical Face Masks
How Nimonik Supports Medical Device Companies
Easy Access to Industry Standards
Access all of the industry standards that your organization requires. Access ASTM standards alongside other standards in a unified platform. There is no need to access ASTM Compass.
Leverage Workflow Tools
Leverage powerful workflow tools and features to make the most of your documents. Nimonik’s platform includes AI-enhanced document comparisons, usage reports, audit tools, assignable actions, and much more!
Stay Updated with Regulatory Changes
The Nimonik Regulatory Updates Newsletter and Library enable you to monitor proposed and current changes to laws, regulations, and industry standards, ensuring proactive compliance management.
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
The onboarding process was easy and went smoothly. The whole team was very helpful with our requests. Your help researching our options was very beneficial. I feel like you were a great advocate for us.
– Director of Operations at Medical Device Company
Nimonik — One Platform to Manage Your Requirements
Nimonik aggregates standards from 90+ publishers, including ASTM, and regulations across 600+ jurisdictions. As a result, Nimonik provides broad coverage and convenience, allowing medical device teams to track and manage obligations in one easy location. If you need custom lists, complete with historical updates, and robust workflow tools, Nimonik is the ideal choice.
Your Industry Standards Solution Starts Here
Access, manage, and monitor the industry standards your operations rely on. Connect with an expert to streamline your standards management and ensure consistent, up-to-date access across your organization.
