ISO 13485 Compliance Consulting & Audit Support Services
ISO 13485 Compliance —
Medical Device Quality Management System
The internationally accepted standard of Medical Device Quality Management System is known as ISO 13485, which is developed especially to target the organization that is involved in the design, development, production, installation and servicing of medical devices.
Our ISO 13485 compliance and consulting services are used to assist medical devices manufactures and suppliers in complying with regulatory requirements, enhancing product quality and gaining confidence in certification to ISO 13485.
What Is ISO 13485?
The ISO 13485 is a quality management standard that is specific to the medical device sector. It is concerned with satisfying regulatory demands, risk management, product safety, and uniform quality all through the product life cycle.
The ISO 13485 standard builds on the concepts of ISO 9001 and incorporates medical-device-specific requirements in the areas of risk management, design controls, and validation, as well as regulatory compliance. In the case of many organizations, the ISO 13485 is regarded as ISO 9001 of medical devices.
Benefits of ISO 13485 Compliance
1. Medical Devices Regulatory Compliance
The ISO 13485 assists the organization in fulfilling quality medical devices regulation demands across countries and internationally. It offers a systematic approach towards adhering to laws, standards and regulatory requirements minimizing the chances of failure to do so and the repercussions.
2. Better Quality of Products and Patient Safety
The standard aims at quality control, risk management, and process validation. This makes medical devices safe, reliable, and always able to satisfy customer and patient safety requirements.
3. Good Risk Management in the Product Lifecycle
Risk identification, evaluation, and control at all the phases, including design and development, production, and post-market operations, are required by ISO 13485 to assist in avoiding a product failure and safety problems.
4. Increased Process Control and Consistency
With the use of a medical device quality management system, organizations would be able to standardize their operations, minimize errors, and ensure similar product quality within batches and production lines.
5. Growth in Customer and Market Confidence
The ISO 13485 certification proves your interest in quality and adherence to regulation, which enhances your credibility with customers, medical service providers, regulators, and business partners.
6. Better Supplier and Vendor Management
The criterion demands rigid assessment and observation of suppliers. This will guarantee the quality and regulatory needs of raw materials, components, and the outsourced processes.
7. Less Product Recalls and Nonconformities
Through good documentation, traceability and corrective action procedures, ISO 13485 will assist in detecting problems at the early stages and eliminate the possibility of expensive recalls or defective products.
8. Persistent Improvement Readiness & Auditing
Internal audits, reviews by the management and corrective measures are part of the routine of organizations to keep on enhancing its quality system and to be ready in case of regulatory and certification audits.
Our ISO 13485 Certification Compliance Services
We offer custom assistance on the end-to-end support of helping organizations to fulfill all the ISO 13485 requirements and ensure their long-term compliance.
Quality Management System (QMS) Development
We assist in the design and implementation of a strong ISO 13485 Quality Management System that is in line with your product, processes, and regulatory requirements.
Support of regulatory & risk management
We help in the determination of risk management processes in the product lifecycle such as design, production, and post-marketing processes.
Documentation Development
We maintain all the necessary ISO 13485 records such as quality manuals, procedures, work instructions, risk files, validation records and technical documentation.
Supplier & Process Control
We assist in applying supplier qualification, purchasing policies, production surveillance, and traceability to maintain the same quality medical devices.
Internal ISO 13485 Audit
Internal audits are done on system effectiveness and gaps are found prior to certification.
Incessant Improvement Support
We favor corrective measures, CAPA procedures, and system enhancements in order to ensure compliance.
ISO 13485 Consulting & Training Services
We have qualified ISO 13485 consultants who offer professional advice and training during the implementation and certification.
Gap Assessment
We compare your existing system with those of ISO 13485 to determine the missing components and areas of improvements.
Certification Support and Implementation
We take you through the system implementation stage by step and assist you in passing the ISO 13485 certification audit.
ISO 13485 Training Programs
We offer best training on ISO 13485, and these include:
ISO 13485 awareness training
Training of internal auditor- ISO 13485
ISO 13485 auditor training
ISO 13485 certification training
Team training on 13485 internal audit training
ISO 13485 Certification Requirements
Quality Management System
The development, writing, introduction and support of a medical device quality management system.
Designing and Development Controls
Develop control product designs that are safe, perform at required levels, and meet regulatory standards.
Risk Management
Risk identification, assessment, and management across the medical device lifecycle.
Supplier & Purchasing Controls
Make sure that suppliers have quality and regulatory needs.
Production & Process Control
Have proven and managed production processes.
Corrective Preventive Actions (CAPA)
Determine the problems, explore the cause factors, and carry out corrective measures.
Internal Review Audit and Management
System effectiveness and constant improvement is ensured by regular audits and reviews.
Why Choose Us
The ISO 13485 consulting services provided by KavachOne are aimed at assisting the medical device organizations in developing a compliant, practical, and audit ready quality management system. We are offering correct documentation, practical implementation assistance, and professional audit advice. Having vast knowledge in the medical device quality and regulatory standards, our consultants make it easier to achieve compliance with ISO 13485 and enable organizations to be certified with the least amount of time and maintain product safety and regulatory trust.