Implementation and management of compliance


MedDev Soft specializes in the implementation and management of key ISO standards within the medical industry, particularly for medical device manufacturers. Our focus on ISO standards underscores our commitment to continuous improvement, regulatory compliance, global market access, collaborative development, and patient safety.

Key ISO Standards and Their Implementation:

ISO 27001 – Information Security Management
Implementation: Establishing an ISMS certified to ISO 27001 and additional 27000 family standards, managing information security risks to ensure data confidentiality, integrity, and availability.
Management: Regularly updating the ISMS to address evolving security threats and maintain compliance with the latest information security practices.

ISO 13485 – Medical Devices Quality Management Systems
Implementation: Developing a QMS that complies with ISO 13485, focusing on consistent and safe medical device design, development, production, and post-marketing.
Management: Continual monitoring and improvement of the QMS, including regular internal audits and management reviews.

ISO 14971 – Medical Device Risk Management
Implementation: Establishing a framework for risk management throughout the medical device lifecycle, in line with ISO 14971, to ensure identification, evaluation, and control of risks associated with medical devices.
Management: Ongoing assessment and management of risks, adapting to changes in technology and regulatory requirements, and ensuring continuous risk control.

MedDev Soft’s expertise in implementing and managing ISO standards plays a pivotal role in driving industry excellence and ensuring the highest quality of medical device manufacturing. Our approach ensures that your organization not only meets but exceeds international standards for quality, safety, and efficacy.

Elevate your organization’s standards in medical device manufacturing with MedDev Soft’s ISO compliance solutions. Contact us to implement and manage ISO standards effectively, ensuring excellence and global market success.

ISO Standards Highlights

Continuous Improvement

Promoting a culture of continuous improvement in product quality and process efficiency.

Regulatory Compliance

Meeting regulatory requirements in various global markets, reducing legal risks.

Global Market Access

Facilitating entry into international markets with recognized compliance.

Collaborative Development

Encouraging collaborative practices for enhanced product development and safety.

Patient Safety

Ensuring the highest standards of patient safety through rigorous quality and risk management.

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