PB Consultancy - ISO Consultant

ISO 13485 MEDICAL DEVICE QUALITY MANAGEMENT SYSTEM

The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a Medical device QMS. A medical device is a product, such as an instrument, machine, implant or in vitro reagent that is intended for use in the diagnosis, prevention and treatment of diseases, rehabilitation of illness and disease or other medical conditions. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

KEY BENEFITS OF ACHIEVING ISO 13485 CERTIFICATION TO YOUR ORGANIZATION

Increase access to more markets worldwide with certification
Outline how to review and improve processes across your organization
Increase efficiency, cut costs and monitor supply chain performance
Demonstrate that you produce safer and more effective medical devices
Meet regulatory requirements and customer expectations

ISO 13485 REQUIREMENTS

The ISO 13485 standard contains specific requirements for manufacture, installation and servicing of medical device, which strongly focus on the compliance of EU Directives for MD or IVD such as:

Provision of technical documentation (medical device file / technical product file)
Specific design & development requirements
Implementation of a risk management process to product development and product realization.
Validation of processes.
Health, safety and staff hygiene requirements
Change management, market observations and procedures for product recall
Compliance with statutory and regulatory requirements
Effective product traceability and recall systems.

ISO 13485 DOCUMENTATION REQUIREMENTS

Here are the documents needed for compliance with ISO 13485:2016

Quality policy and Quality objectives.
Medical Device Quality management system manual.
Mandatory procedure for Medical device process management.
Requirements for infrastructure and maintenance activities
Requirements for work environment
Arrangements for control of contaminated or potentially contaminated product
Process for risk management in product realization
Procedure and records for servicing of the medical device, service validation.
Procedure and records for data analysis and corrective actions

ISO 13485 AND CE MARKING?

ISO 13485 is a globally accepted Quality Management Standard which is also accepted as the basis for CE marking medical devices under European Directives and Regulations.
Although ISO 13485 certification is not mandatory for CE marking medical devices under the European Medical Device Directives, it has a strategic approach and process, which allows the presumption of conformity to the Directives.
The PB team has empowered 15+ clients with ISO 13485 services and helped in achieving the standard quality. The trained and experienced professionals at PB Consultancy have provided 50+ training sessions and conducted 35+ internal audits. To enhance the quality of your medical devices and implement ISO 13485, talk to the PB consultants now

HOW ORGANIZATION CAN IMPLEMENT ISO 13485?

The PDCA cycle, or Plan-Do-Check-Act cycle, is a continuous improvement model that organizations use to plan, implement, monitor, and continually improve their processes and products. It is a four-step iterative process that starts with identifying and analyzing the problem or opportunity for improvement in the planning phase, followed by implementation of the plan in the doing phase, monitoring and evaluating the results in the checking phase, and taking actions to improve processes or products in the acting phase. By following the PDCA cycle, organizations can improve their overall performance and achieve their objectives in a structured and efficient manner.

WHO SHOULD IMPLEMENT ISO 13485?

ISO 13485 is primarily created for designers, manufacturers, and distributors of medical devices. In addition, suppliers and service providers can implement the standard and gain a competitive advantage by enhancing the organization’s marketability and recognition.

The Standard is Applicable to

Manufacturing of medical devices (MD) or in vitro diagnostic products (IVD)
Manufacturing of reagents or substances for use in IVD or MD(for pharma and diagnostic purpose
Medical device Traders