MedDeV
Risk Management

RISK MANAGEMENT: ENSURING SOFTWARE SAFETY IN MEDICAL DEVICES

At MedDev Soft, we recognize that risk management is a critical, mandatory aspect throughout the development, production, and maintenance phases of medical devices. Our approach, aligned with ISO 14971 standards, emphasizes procedural and operational implementation of risk management to enhance efficiency and reduce product life-cycle costs.

Risk Management Highlights

Regulatory Strategy and Support
Expert guidance in developing and implementing a regulatory strategy tailored to your product, including device classification consultation.

Premarket Processes
Assistance with premarket clearance and approval, ensuring compliance with MDR and FDA regulations.

Compliance Standards and Validation
Adherence to GAMP guidelines and conducting NPS validation to meet regulatory standards..

Quality Assurance and Quality Control
Implementing QA and QC processes in line with QMS ISO 13485 and 21 CFR Part 820, and utilizing integrated software solutions for ALM and QMS.

MedDev Soft is committed to providing comprehensive support for regulatory compliance, ensuring that your medical device meets all necessary standards and regulations for a successful market launch.

Accelerate your path to market with MedDev Soft’s regulatory compliance expertise. Contact us to navigate the complex regulatory landscape with confidence, ensuring your medical device meets all necessary standards and approvals.

Risk Management in Detail

Regulatory Strategy Development

Crafting and implementing tailored regulatory strategies.

Device Classification Consultation

Assisting in accurate device classification for regulatory pathways.

Premarket Clearance and Approval Guidance

Navigating premarket processes for market access.

MDR and FDA Compliance

Ensuring adherence to EU and US regulatory standards.

GAMP Compliance Implementation

Following Good Automated Manufacturing Practice guidelines.

Non-Product Software Validation

Validating software used in manufacturing and maintenance.

Quality Assurance Processes

Implementing QA standards and procedures.

Quality Control Measures

Adhering to QC standards for product reliability.

Integrated Software Management

Streamlining compliance with regulatory standards using ALM and QMS solutions.

want to know more?

Please leave us a message and we will return to you shortly

see more services

Software Quality
Assurance (SQA)
Software Verification and
Validation (V&V)
Software
Development
Cyber Security
Risk
Management
Consulting &
Training Services
Regulatory Compliance
(MDR/FDA)
Implementation and management of compliance

with ISO standards