Medical Device Quality

ISO 13485 is specification for the quality management system standard for organizations manufacturing medical device.

ISO 13485 is based on ISO 9001 with additional requirements related to design, special processes, documentation, records, tractability, documentation records, and regulatory actions. ISO 13485 requires that the quality system for medical device manufacturing is implemented and maintained.

ISO 13485 is commonly used as the basis for regulatory requirements. ISO 13485 registration does not fulfill the requirements of the various industry regulators, such as those of the U.S. Food and Drug Administration (FDA).

SCOPE & APPLICATION

ISO 13485 specifies requirements for a QMS where an organization needs to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The aim of this standard is to facilitate regulatory requirements for medical device quality management systems. This includes requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory Requirements. Because of these exclusions, organizations whose quality management a system conforms to this international standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.

ISO 13485 is applicable to:

Companies, who design, manufacture, distribute, install and service medical devices for the European and World markets.
Companies who manufacture OEM products which are sold under other company names.
Companies who design and/or manufacture medical device components or raw materials for the medical device market.
Companies selling, installing or servicing medical devices.
Consultants providing design services to the medical device market.
Companies providing services to the medical device market such as sterilisation, cleaning, testing, etc.

ISO 13485 REQUIREMENTS

General Requirements

The organization shall

identify the processes of the organization & interaction of these processes,
determine operational controls to ensure processes are effective,
control any outsourced processes that affect product conformity
ensure the availability of adequate resources and information
monitor, measure and analyse processes, and
implement necessary actions to achieve planned objectives and targets

Documentation Requirements

The quality management system documentation shall include:

quality policy and quality objectives,
quality manual,
documented procedures & work instructions,
documents and records needed for effective implementation of processes,
Quality requirements by the applicable regulatory authorities.

The extent of the ISO 13485 documentation can vary from one organization to another due to:

the size of the organization and type of activities,
the complexity of processes and their interactions, and
the competence of personnel.

ISO 13485 IMPLEMENTATION BENEFITS

ISO 13485 implementation improves / leads to

POLICIES & OBJECTIVES set by 'top management'
Conformance to Legal and Regulatory Requirements
Recognition by regulators around the world of ISO 13485:2016 as a good basis for addressing medical device design and manufacturing regulatory requirements
Controlled consistency of manufactured products
Managed productivity and efficiency, controlling costs
Competitive advantage and increased marketing and sales opportunities.
Improved customer perception of the organization’s image, culture and performance .
improved internal and external Communications
greater understanding of the organization's processes
clear responsibilities and authorities agreed for all staff
improved use of time and resources
reduced wastage
greater consistency and traceability of products and services
Customer Confidence, Satisfaction and TRUST
Level of Assurance in Organisational QUALITY
Organisational PROFITABILITY
Ability to Differentiate Organisation for Competitive Advantage
Organisational Credibility & Reputation

WHY CHOOSE SGQ Innovations?

Team SGQ Innovations has IRCA certified ISO 13485 auditors for Consulting Services
Hands on experience of Team SGQ Innovations in implementing ISO 13485 will help to gain early benefits

TRAINING

We offer a customized training program on ISO 13485 for

ISO 13485 - Implementation and documentation requirements
ISO 13485 - Internal Auditor training

CE Marking With the CE-marking the manufacturer or his representative within the EU declare that the individual product is in compliance with the general safety regulations in the CE-marking directives. We offer you a wide range of services that support the CE Marking.

FDA 510(k) Review

Review of 510(k) submitter on behalf of FDA (Food and Drug Administration). UL performs the review of the 510(k) application and recommends a substantial equivalence decision to the FDA. The FDA makes the final market clearance decision. Huge time saving! Market clearance can be achieved in 45 days or less.

ISO 14971:2012

ISO 14971 is an international standard for risk management of medical devices. It is recognized by the US Food and Drug Administration (FDA), European authorities, Health Canada, the Australia Therapeutic Goods Administration and other regulators as the "de facto" standard for risk management of medical devices. ISO 14971 is an integral part of a quality system and should be incorporated into the life cycle process of medical devices. The purpose of ISO 14971 is to establish, document and maintain a risk management process to: Review the intended use of the medical device. Identify hazards and estimate the probability that harm might occur. Estimate the severity of each hazard and evaluate the associated risks. Control those risks and monitor the effectiveness of the controls put in place.

Why choose SGQ as your ISO 14971 consultants for medical device risk management:

• We specialize in quality assurance for medical device and IVD companies.

• Our consulting team has implemented number of FDA QSR and ISO 13485 quality systems at medical device companies making a wide range of Class I, II and III devices.

• Our experienced team of consultants is skilled at identifying and reducing risk in all types of devices and processes.

• We have extensive experience integrating ISO 14971:2012 into existing ISO 13485 and FDA GMP quality management systems.

• SGQ is widely known in the industry for providing high quality consulting to medical device companies.