ISO 13485 Certification

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ISO 13485 Medical Device Quality Management System is an international standard that sets out the requirements for a quality management system specific to the medical devices industry. It is designed to be used by organizations throughout the life cycle of a medical device, from initial conception to production and post-production, including final decommission and disposal. It also covers aspects such as storage, distribution, installation and servicing, and the provision of associated services.

ISO 13485 demonstrates an organisation’s competency to deliver high-quality and safe medical devices. Moreover, it exhibits the organisation’s responsible behaviour towards the safety and well-being of clients, customers, and stakeholders.

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ISO 13485 QMS will help you:

Protect your company reputation as a responsible organization committed to quality and safety in the medical product sector.
Save costs by process optimization which allows organizations to establish a culture of continuous improvement and to eliminate deficiencies, which in turn reduces associated expenses; as well as to establish processes to manage risks and eliminate costs effectively.
Create new business opportunities since some organizations in the healthcare and medical device manufacturing sector demand that their suppliers are certified under this standard.
Gain competitive advantage especially since some national regulatory authorities require or strongly prefer medical device producers that have a certified management system in place. Investing in such a QMS speeds up access to those countries require it.
Demonstrate compliance with customer and regulatory requirements.

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Scope of ISO 13485:2016 Certification

ISO 13485 Certification divides the medical devices into two categories. These are:

  • Active Medical Devices
  • Non-Active Medical Devices
    Non-Active Medical are further classified into five broad categories; these are as follows:
  • General Non-Active, Non-Implantable
  • Medical Devices
  • Non-Active Implants
  • Devices for Wound Care
  • Non-Active Dental Devices and Accessories
  • Non-Active Medical Devices other than specified above

    • Seven Principles of ISO 13485 Certification

    ISO 13485:2016 Certification for Medical Devices – Quality Management Systems (MD-QMS) works on the seven pillars to meet the intended quality objectives and goals. The seven principles of ISO 13485:2016 Certification are as follows:

  • Customer focus –It aims to improve for the betterment of the interested parties and customers. Moreover, this will help the organisation sustain customers and increase its customer base by meeting their needs and requirements. The certification ensures to communicate its vision and mission by meeting the needs and requirements of clients and customers.
  • Leadership – Leaders must establish unity of purpose by aligning their strategy, policies, procedures and resources to achieve quality objectives. Moreover, this will lead to better coordination of the organisation’s processes. The certification also establishes a culture of trust and integrity by providing people with the required resources, training, and authority to act with accountability.
  • Engagement of people –Organisations must communicate the quality requirements and objectives with the employees to achieve the desired goals and objectives. Moreover, an organisation must share its knowledge and experience to enhance employees’ participation and people’s contribution to boost their morale.
  • Process approach –The certification provides the organisation with a process-based approach to streamline various processes and operations to attain quality objectives.
  • Improvement-The principle of continuous improvement is an integral part of Medical Devices – Quality Management Systems (MD-QMS). organisations must maintain the current level of performance and keep on setting new quality benchmarks by giving proper training, reviewing and audit planning.
  • Evidence-based decision-making –Organisations can learn from mistakes and encourage the organisation to make decisions based on past evidence. Moreover, this will help one implement efficient solutions by adding more facts and information to support its actions.
  • Relationship management –An organisation must manage relations with the stakeholders and interested parties such as providers. The organisation can achieve this by keeping a well-managed supply chain that provides a stable flow of products and services and determining the interested party’s relationship.

    • Benefits of ISO 13485:2016 Certification

    ISO 13485 is helpful for organisations in all stages of the product life cycle- starting from its design development, manufacturing, storage, and distribution of the final product. The applicability of ISO 13485 does not stop at that. It can also be applied for relevant services of medical devices along with associated activities that are in the form of technical support- both remote and on-site.

    Since ISO 13485 is an internationally recognised standard, building an MDQMS helps an organisation to reap the unfathomable benefits. It tremendously reduces your costs. Some of the many benefits of ISO 13485 certification are listed below :-

  • An improved process results in reduced costs.
  • Better reliability of the management results in stronger relationships with the stakeholders.
  • ISO 13485 certification boosts your image and makes you trustworthy in the eyes of customers.
  • An effective QMS for medical devices will ensure the quality and consistency of products when strictly adhered to the ISO 13485 requirements.
  • The global acceptability of ISO 13485 certification enables a wider market reach for your business.
  • The Global Harmonization Task Force (GHTF) recognises the ISO 13485 certification as the standard for establishing model MDQMS for medical industries. In addition to that, ISO 13485 covers all legal and contractual requirements.
  • ISO 13485 also covers the requirements of the Food and Drug Administration (FDA).

    • Operational Risk Management

    Our focus is on supporting clients in establishing robust guardrails that minimize the risk of reputational damage or regulatory penalties. By working closely with organizations, we help them develop and implement clear guidelines and protocols that align with regulatory requirements and best practices. These guardrails serve as a framework for ethical and compliant conduct, safeguarding the organization's reputation and reducing the likelihood of negative consequences.

    • Client success in Risk Management and Compliance
    85%
    Expected loss reduction

    We assisted a leading merchant acquirer in the travel and airline industries with risk management and compliance, resulting in reduced exposure, lower expected losses, and increased profitability in high-risk sectors during a crisis. We successfully reduced the client’s exposure by over one-third and mitigated expected losses by approximately 85% during this turbulent period.

    5%
    Uplift

    A global USA bank partnered with us to enhance their treasury, asset and liability management operating models, as well as their liquidity and interest rate risk management process. Through this transformational engagement, we made revisions to the client’s behavioral models and hedging strategy

    >10
    Automotive industry

    We designed and implemented a global integrity and compliance program for a world-leading automobile manufacturer. The program focused on implementing processes and inspiring people, strengthening governance and processes across more than 500 legal entities worldwide. Through diverse communication, training, and enablement initiatives, we engaged all employees on the path to achieving sustainable culture change.

    Client results

    Explore our success stories to see how we have helped businesses like yours overcome challenges and achieve tangible results.

    Breaking New Ground: A Case Study on Market Expansion for a Retail Brand
    Assisting a company in entering a new market and achieving rapid growth.
    From Legacy to Digital: Successful Digital Transformation for a Financial Institution
    Guiding a client through a digital transformation journey to enhance competitiveness and customer experience.
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