- Medical Device QMS Implementation GAP Analysis
- Fill the GAPS by preparing necessary documents with the support of the in-house team
- Implement procedures and necessary work instructions/ SOP’s
- Calibration and validation wherever necessary
- Understanding your activities and planning for Certification
- Identify certification body
- Invite for the Certification audit
- Onsite Audit
ISO 13485 Consultants
ISO 13485 Consultants: Medical Device Quality Management System (ISO 13485) is the most common QMS system prevailing regulatory standard globally for Medical Device organizations. ISO 13485 more focus on regulatory compliance and customer requirements. ISO 13485 focuses on safe design, development, manufacturing controls, and distribution. ISO 13485 is well accepted in Asia & Europe.
ISO 13485 Certification plays a crucial role in a medical device manufacturer, trader, or designer. They help build trust and become a mandatory requirement for Medical Device Regulation MDR 2017/745 & In-vitro Diagnostic Device Regulation IVDR 2017/746.
As an ISO 13485 certified firm, we take our commitment to providing clients with high-quality products and services very seriously. Acquiring the knowledge and abilities required to manage an ISO 13485 framework displays our dedication to assisting your firm in ensuring continual development and improved work procedures. It also shows that you understand the importance of medical device safety and performance and how a quality management system can ensure it, ultimately leading to customer satisfaction. It can also present you with new options, such as working for giant corporations that provide high-quality products and services.
EN ISO 13485: 2016 / BS ISO 13485:2016 are other leading versions applied in other countries. US FDA regulation described in QSR 21 CFR 820.
ISO 13485 (MDQMS) Certification Bodies
The International Organization of Standardization only creates and maintains standards; it is not a regulatory or enforcement agency that requires organizations to implement or certify. ISO 13485 certification is possible with the participation of third-party certification bodies following an onsite audit against the most recent version of the standard. The ISO 13485 certificate is valid for three years. Various types of certification bodies issue certificates, some of which have International Accreditation and some of which do not.
Stages of Certification
Role of Our Team as ISO 13485 Consultant
- Understanding your activities and planning for strong Implementation
- Identify a suitable Certification Body if the organization is interested in Certified
- Identify the necessary procedures and do the initial drafting of mandatory procedures
- Discuss the drafted procedures with the process owner and develop the formats
- Will provide Draft Quality Manual
- General awareness training and internal auditor training
- Conduct Internal auditing with the support of the in-house team
- Support in identifying the critical process.
- Support in Validation and development of necessary protocols
- Verify the quality plans and specifications
- Internal audit support and closing the Non-conformities
- Guidance on statutory and regulatory requirements of the product
- Corrective and Preventive Action (CAPA)
- Support during External audit
- Support for closing the non-conformities
Clauses in the ISO 13485 Standard
Clause 4: Responsibility Quality management system
Clause 5: Management Responsibility
Clause 6: Resource management
Clause 7: Risk-Based Approach to Product Realization
Clause 8: Defined Processes for Measurement, Analysis and Improvement
Medical Device Quality Management System (ISO 13485) Certification Timeline
Small and medium sized manufacturing companies expected to take around 3-4 months for Implementation and 2 months for the certification audit process.
Medical Device Quality Management System (ISO 13485) Certification Cost
Consultation and Internal Audit service service will cost approximately $6000 – $8000 for small company. The certification will cost approximately $4000 to $6000
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