ISO 13485 Certification Increasingly Key for Medtech Industry Success

by Genesis Plastics Welding Marketing Team Genesis Plastics Welding Marketing Team

1The ISO 13485 certification is a driving force in harmonizing quality, safety and overall business performance within the medical device industry. A recent Medical Device and Diagnostic Industry (MDDI) Magazine article highlighted the growing interest amongst medical device manufacturers in conforming to ISO 13485 regulatory requirements.

As an ISO 13485 certified contract manufacturer, our Genesis team has experienced firsthand just how beneficial the certification can be in keeping both our medical device OEM clients and ourselves on track to achieving business success within the industry. For example, the standard’s global recognizability by many governments gives instant credibility with potential customers – making access to new markets much easier.

ISO 13485 compliance means manufacturers take a risk management approach to identify, control and eliminate potential risks throughout production. For years, our medical device customers have partnered with us because we adhere to strict industry standards,  and maintain transparent quality systems and efficient processes thanks in part to upholding the ISO 13485 standard.

The sections of the MDDI article included below will give you better insight into why so many manufacturers now aim to be ISO 13485 compliant and just what goes into achieving a certification.

Achieving ISO 13485 Compliance

ISO 13485 was authored by the Geneva–based International Organization for Standardization (ISO), the world’s largest developer of international standards. In order to avoid compromising their competitiveness, medical device manufacturers are being pressured to comply with this standard. Indeed, for companies seeking access to international markets, conformity with ISO 13485’s regulatory requirements is fast becoming a universal prerequisite.

From 2004 through 2012, a total of 22,237 ISO 13485 certificates were issued worldwide in 93 countries, according to the ISO. From 2010 to 2012, company certifications rose a cumulative 18%—an average of 6% per year. In 2012 alone, the percentage of certifications doubled, increasing by 12% percent. Overall, the number of certifications in 2012 was 240% higher than that in 2011. In 2012, ISO certifications were highest in Italy, the United States, and the UK, Today, the largest number of certified companies is in the United States, followed by Germany and Italy.

ISO 13485 defines a medical device as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other similar or related article that is intended by the manufacturer to be used alone or in combination. Receiving ISO 13485 certification requires an evaluation of all aspects of a company’s business processes and procedures to confirm conformity with the requirements outlined in the standard. Registration signifies that a manufacturer has implemented an integrative management system that complies with the applicable regulatory requirements for quality management.

To achieve ISO 13485 certification, companies must develop written policies for executing the following tasks:

  • Document and record controls.
  • Internal auditing procedures.
  • Controls for nonconformance.
  • Corrective and preventative actions.
  • Process and design controls.
  • Record retention.
  • Accountability and traceability.

By achieving ISO 13485 certification, medical device manufacturers can hope to gain

  • Access to markets that recognize or require certification, including Canada and Europe.
  • Reduced operational costs by highlighting process deficiencies and improving efficiency.
  • Increased customer satisfaction by consistently delivering quality products and systematically addressing complaints.
  • Proven commitment to quality by adhering to an internationally recognized standard.
  • Added transparency in handling complaints, surveillance, or product recalls.

Read the MDDI article in its entirety to find out more about how ISO 13485 compares to other ISO standards, its impact on patient safety and how it helps OEMs enter new global markets.