Feature Article : Medical Device Manufacturing Trends – ISO 13485 Revision Preparation
Medical devices include a range of products designed to diagnose and treat patients in healthcare systems worldwide. From tongue depressors to highly technical imaging systems, key products that comprise the industry include surgical appliances and supplies, surgical and medical instruments, electro-medical equipment, irradiation apparatus, in-vitro diagnostic substances, dental and ophthalmic goods.
According to a SelectUSA report, the United States remains the largest medical device market in the world with a market size of around $110 billion, and it is expected to reach $133 billion by 2016. The U.S. market value represented about 38 percent of the global medical device market in 2012. Japan, EU, China, Brazil, Taiwan, Hong Kong and Australia also represent significant medical device markets.
Emergo issued a Global Medical Device Industry Outlook for 2015 based on feedback from over 5,400 industry professionals and concluded the industry remains stable and faces challenges over the year that primarily include pricing, regulatory and reimbursement related factors.
The key takeaways of this international industry survey include:
• Companies expect China and U.S. markets to perform well in 2015 compared to others.
• 75% of those surveyed are positive about prospects for the industry in 2015.
• Companies located in North/South America and Asia are more optimistic than those located in Europe.
• Other countries have become more difficult from a regulatory compliance perspective. These include China (uncertainty about clinical trial requirements and lack of English documentation), Japan (PMDA enforcement), Russia (lack of transparency and English documentation) and Brazil (BGMP audit queues).
As the demand for medical devices continues to grow, Pro QC assists organizations involved in the industry by performing comprehensive product quality inspections throughout production and by conducting preliminary and/or final ISO 13485 assessments to ensure continuous improvement goals are being identified and achieved.
ISO 13485:2003 is a standard based on ISO 9001 and specifies requirements for a medical device manufacturer to maintain a quality management system. According to the standard, these requirements “can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development and provision of related services.”
Arlen Chapman, quality systems director for NQA, notes, “Medical device manufacturers want to realize better products and better services. I see it more from the financial standpoint for them-for cost savings, making sure they have good suppliers, that they’re communicating with them properly and managing them properly.”
Pro QC incorporates the following components during a factory assessment:
Section 4: Quality Management Systems
Control of documents and records
Section 5: Management Responsibility
Quality manual and policy
Objectives and planning
Section 6: Resource Management
Section 7: Product Realization
Identification of customers’ requirements
Design and development
Purchasing of raw material and control
Production and service provisions
Control of monitoring and measuring devices
Section 8: Measurement, Analysis and Improvement
Internal measurement of processes and product
Control of nonconforming product
Analysis of data
Corrective and preventative action
ISO standard revisions for 13485 were originally scheduled for release this year. However, due to the high volume of comments received by the ISO Technical Committee, the 13485 revision is planned for early 2016. It is currently referred to as ISO 13485:201X, or DIS (Draft in Standard).
The proposed revisions are significant, and it is important for medical device organizations to start preparing.
Three changes that are speculated include:
1) Due to the increasing complexity of the international regulatory environment for medical devices, it is expected that ISO 13485:201X will incorporate EN ISO 13485:2012 elements and reflect more current requirements by the EU.
2) ISO 13485:201x will reach the entire supply chain in the medical device industry. It is noted that while the existing version is mainly tailored to device manufacturers, the DIS aims to be relevant to suppliers of components and services as well.
3) The revisions will incorporate the entire lifecycle of a device. The current standard focuses on quality up to the point where the device is purchased by the consumer.
As noted, the benefits of performing ISO 13485 based audits go beyond required certification. With an effective and efficient quality system, organizations are able to identify errors early in the process, avoid costly regulatory fines and provide employees with appropriate training.
According to Quality Digest, “there is more than one way to save money by adhering to ISO 13485 standards. Having a quality management system [based on ISO 13485 standards] at an early stage provides another advantage to these companies [medical device companies]: quicker market access. Many regulatory organizations were involved in the development of this standard. Therefore, requirements in regulatory laws such as the 93/42/EEC MDD share numerous similarities with ISO 13485. Hence, after a simple update of their systems, these companies can quickly and cost-effectively seek regulatory approvals from a variety of countries.”
Versions of ISO 13485 include:
• ISO 13485:2003 – Current international version
• EN ISO 13485: 2012 – European harmonized version
• ISO/TR 14969:2004 – Guidance document
• CAN/CSA-ISO 13485:03 – Conformance to this standard is necessary in order to secure a
Canadian Medical Device License for a Canadian class II, III or IV medical device.
Even in countries where adherence to the standard is not required by law, ISO 13485 is becoming increasingly required by investors, partners and customers. Contact us for additional information regarding ISO 13485 medical device supplier audits and quality inspections. We reduce quality risks and cost in over 38 countries.