- 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 certification is valid for three years. Various types of certification bodies issue certificates, some of which have International Accreditation and some of which do not.
Our Services
Quick Contact
We will respond to you within one working day.