Medical Device Industry
The medical device industry covers a diverse range of products, from simple tools to complex implantable devices and smart technologies. With a primary focus on patient well-being, the industry is subject to strict regulations and standards that continue to evolve.
Nimonik: Your Compliance Partner in the Medical Device Industry
Our suite of compliance solutions is tailored to address the unique challenges of the medical device industry, ensuring that companies can navigate regulations effectively and maintain product quality and competitiveness.
How Nimonik Supports Your Compliance Needs
- Access Industry Standards: Our standards subscription service provides access to industry standards, allowing your team to consult regulations on a need-by-need basis.
- 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
I can’t begin to tell you how informative and helpful the Nimonik is…
– Technical Lead at Medical Device Company
List of important Standards for Medical Device Industry
Medical Device Standards Top Selling Medical Device Standards
ISO 10993 Series Standards Complete List of the ISO 10993 Standards on Biological Evaluation of Medical Devices
IEC 60601 Series Standards Complete list of the IEC 60601 Standards on Medical Electrical Equipment
ASTM Standards on Surgical Implants Complete List of ASTM Standards on Surgical Implants
Medical Devices Directive Complete List of the Harmonized Standards for 93/42/eec
Active Implantable Medical Devices Directive Complete list of the Harmonized Standards for 90/385/eecIn Vitro Diagnostic Medical Devices Directive Complete list of the Harmonized Standards for 98/79/ec
Changes to the list of recognized standards in Canada
Recognized Standards USA
Recognized Standards EU
FAQ
Nimonik offers a suite of compliance solutions tailored to the unique needs of medical device companies. Our platform provides access to industry standards and regulatory updates, allowing companies to stay informed about changes that may affect their operations. Additionally, our tools facilitate documentation management, audits, and regulatory reporting, streamlining compliance processes.
Yes, Nimonik’s compliance solutions are flexible and customizable to accommodate the specific requirements of each client. Whether it’s adapting to different regulatory frameworks, integrating with existing systems, or scaling solutions according to business size, we work closely with our clients to tailor our offerings accordingly.
Nimonik prioritizes data security and confidentiality. Nimonik is ISO 27001 certified and our platform adheres to industry-leading security standards and protocols to safeguard sensitive information. We employ encryption, access controls, and regular security audits to ensure the integrity of our clients’ data.
Nimonik offers The Nimonik Regulatory and Standards Updates Newsletter and Compliance Library, which allows companies to monitor proposed and current changes to laws, regulations, and industry standards. Our platform covers updates from over 30 standard development organizations, enabling proactive monitoring of regulatory changes relevant to the medical device industry.
By centralizing compliance management processes, providing real-time updates on regulatory changes, and offering tools for documentation management and audits, Nimonik’s solutions help medical device companies streamline their compliance efforts. This leads to improved efficiency, reduced risk of non-compliance, and increased focus on innovation and business growth.
