Importance of ISO13485 for Medical Device Development

post1.jpgIn the U.S., the medical device industry represents a $140 billion market – about 40% of the global total. Over 80% of U.S. medical device companies employ fewer than 50 people, demonstrating the huge opportunity for small enterprises alongside established players.

It should come as no surprise, however, that success in medical devices means overcoming compliance challenges. The business case for quality compliance is undeniable – McKinsey points out that quality affects every stakeholder in the medical value chain. Quality is a central concern from product design through manufacturing and marketing.

The cost of quality failure is steep: In 2013, Johnson & Johnson agreed to a settlement of $2.5 billion paid to more than 8,000 patients who had their metal-on-metal hip implants replaced with another device after fretting and corroding of the components.

Luckily, quality compliance – though complex – does not mean reinventing the wheel.

ISO 13485 Is the Gold Standard in Medical Device Quality Management Worldwide

ISO 13485 is an international standard for medical device quality assurance that provides complete guidance across the value chain. This allows an organization to show commitment and capability in delivering devices that consistently meet regulatory standards.

ISO 13485 covers the end-to-end medical device process:

  • Design and development;
  • Production;
  • Storage and distribution;
  • Installation or servicing of medical devices;
  • Provision of related services, such as technical support.

In the ISO 13485 quality regime, all elements of medical device commercialization remain under the purview of the organization to be certified, even those performed by a third-party such as an outside contractor. This allows organizations to deliver on their commitments even if they have a complex supply chain involving many participants.

How ISO 13485 Adherence Can Help Your Enterprise Achieve Success

ISO 13485 demonstrates to regulators, officials, and other key industry players your company can be relied on to reach exacting standards every time. Working with an engineering partner who maintains ISO 13485 accreditation helps you crucial ways:

  • You can develop, realize, and prototype innovative, disruptive products faster;
  • You can attain efficiency and cost-effectiveness without sacrificing on quality;
  • You can accelerate FDA approval and potentially beat competitors to market;
  • You can move forward with ambitious projects confident in your quality regime.

Only firms with complete accreditation in all steps of medical device commercialization truly ensure compliance. Anything less introduces complexity, confusion, and greater risk of adverse events that could put a premature end to your business plans.

The Medical Device Commercialization Lifecycle: An Overview

Like other products, medical devices have a complete lifecycle calling upon enterprises to show a wide range of competencies. Devices are developed and realized, enter the market, reach maturity, and are superseded by new technologies. Quality must be maintained at each step.

In particular, ISO 13485 lays out requirements for five broad categories of activity:

Design and development

Design and development requires the organization to define and document all development stages, including pertinent review, verification, validation, and design transfer activities required at each stage and the relevant division of authorities. To meet compliance requirements, all design processes should take into account the appropriate inputs:

  • Functional, performance, and safety requirements based on the device’s intended use;
  • Applicable statutory and regulatory requirements in the intended markets of operation;
  • Data, including for example safety “lessons learned,” derived from similar designs;
  • Other requirements identified as essential for design and development of the device;
  • Outputs of the risk management process.

Development is, by its nature, a complex and iterative process. Its ultimate goal is to produce appropriate outputs that facilitate safe production and commercialization. Because development can take place over many years and may include thousands of stakeholders worldwide, a review process is essential for ensuring that appropriate progress is achieved and documented.

During design and development, Technosoft Innovations empowers clients to focus internal resources on customer and regulatory requirements. Through a rigorous in-house review process, it frees the client from excessive overhead and on issues like documentation and scope change. This greatly accelerates the process while ensuring it continues to conform to the highest standards.


Production is the phase that builds on design and development outputs to ensure manufacturing logistics can be carried out. Production of a medical device must be executed according to precise standards in cleanliness and safety using suitable equipment. It is necessary for procedures, requirements, and work-related materials to be documented fully.

Under ISO regulations, controlled conditions can include any or all of the following:

  • The availability of documentation describing the product’s characteristics;
  • Documentation for procedures, requirements, work instructions, reference materials, and reference measurement procedures as required;
  • The use of appropriate equipment;
  • The availability and use of appropriate measuring and monitoring devices;
  • The implementation of appropriate measuring and monitoring as needed;
  • Implementation of pertinent release, delivery, and post-delivery activities;
  • Implementation of required standards for device labeling and packaging.

It needs hardly be said many enterprises will engage in medical device research, development, and commercialization without an in-house manufacturing footprint. ISO standards account for this and foster complete visibility throughout the supply chain. Third-party activities, which may include manufacturing and fulfillment, fall under the internal quality management regime.

Technosoft Innovations significantly streamlines, simplifies, and controls manufacturing through expertise in inspection and compliance. Our teams can assist organizations in the selection of manufacturing and logistics partners and ensure all partners maintain impeccable standards. This helps mitigate risk while providing for appropriate scaling of operational activities.

Storage and Distribution

Storage falls within the more general category of “preservation of product,” ensuring a medical device maintains its conformity with regulations during internal processing and delivery. This accounts for the fact that inventory lossage can and does occur between production and product installation.

Though the most severe storage challenges apply to products with a limited shelf life, it remains imperative to control and record storage conditions and to manage distribution carefully. This protects against damage and deterioration while a batch of product is in transit.

Defined activities under ISO 13485 include:

  • Identification;
  • Handling;
  • Packaging;
  • Storage;
  • Protection.

The distribution phase can provoke anxiety within organizations, as relatively few third-party logistics providers maintain applicable standards to minimize risk. Likewise, it is crucial for all logistics stakeholders to offer complete, accurate traceability of batches in transit.

Technosoft Innovations works with clients to thoroughly vet partners in storage and distribution. Through deep understanding of regulatory compliance requirements, it becomes possible to focus attention on partner enterprises capable of maintaining the required Service Level Agreements.

At a certain point, it may become desirable for medical devices enterprises to maintain their own storage and distribution facilities. Technosoft can work with your in-house logistics team to drive the development of facilities that conform to ISO 13485 and other standards.

ISO 13485 is an international standard, so its requirements are applicable throughout the supply chain. With each region, nation, and territory operations touch on, more complexity is added. Most enterprises find that a compliance partner can help them leverage economies of scale, cutting overall costs and reducing risk even when significant capital assets are maintained.

Installation or Servicing of Medical Devices

The popular imagination is captivated by the ability of small medical devices, such as stents, to make a dramatic difference in a patient’s well-being. However, medical capital equipment such as diagnostic technology represents an area of major revenue and growth potential. With size and complexity of a device, its installation and servicing requirements will become more taxing.

Many medical devices cannot be fully validated until they arrive at the final customer site and are installed. In this case, the distribution phase is not considered to be complete until the final validation occurs. This underscores the interrelationship between phases of the medical device lifecycle and the need for stakeholders with end-to-end compliance knowledge.

Installation relies upon the development of documented acceptance requirements for installation and verification. Customer requirements may permit for installation to be performed by others aside from the organization and its authorized agents – in this case, the organization must furnish documented requirements for the installation and verification.

Servicing encompasses repair, maintenance, and related activities. In general, servicing demands the development of appropriate documentation and standards comparable to those created in the development phase. Documentation requirements grow more stringent for servicing of sterile equipment. Validation is essential to ensure that the device can return to regular use.

Both installation and servicing require long-term maintenance of documentation. Documentation continues to accrue throughout each customer’s lifetime. As processes are amended, changes must be disseminated rapidly. Technosoft Innovations will help you develop the processes, procedures, and related infrastructure to ensure the enterprise is both compliant and nimble.

Provision of Related Services, Such as Technical Support

“Related services” is a general term expressing all of the expertise an organization continues to offer its customers following distribution, installation, and validation. As it is, by nature, quite broad, the first step is to define and delineate the scope of such services.

Scope may vary over time and according to the needs of specific customers, but should remain within the purview of the organization’s expertise. With this in mind, one of the most common elements of “related services” is ongoing technical support.

Technical support and equipment servicing are closely related. Errors or omissions in either of these processes can introduce unintended performance consequences for the final customer. It is necessary to ensure complete documentation and dissemination of all related processes.

Technosoft Innovations works with its clients to clarify and manage the scope of lifecycle services to be provided to customers. Services must be defined and contracted in a way that allows the organization to meet its obligations and develop its market presence. Without an appropriate operational philosophy for ongoing services, they can erode margins significantly.

Technical support in particular is another area where many enterprises will explore business process outsourcing. As these services touch directly on the specific deployment of equipment at customer sites, they may introduce compliance requirements above and beyond what is covered by ISO 13485 – in particular, data security standards protecting confidential information. With that in mind, a rigorous vendor selection process (often including RFP) is essential.

Technosoft Innovations Makes it Easier than Ever to Deliver Industry-Leading Quality

Meeting all applicable quality standards for medical devices is no small feat. Each aspect of medical device commercialization introduces its own requirements, which are iterative. The ability to succeed in any future step depends upon flawless achievement of the previous one. One oversight, particularly for a new enterprise, may doom an otherwise commendable effort.

Regulations, then, are a double-edged sword. They equip healthcare providers and patients alike with the confidence to move forward on medical innovations that can be truly life-changing. However, they also grant to companies a solemn burden of responsibility that represents one of the highest barriers to entry in the medical device sector.

Technosoft Innovations recognizes both the challenge and the opportunity this presents.

North Carolina-based Technosoft Innovations has helped medical device developers achieve their objectives worldwide by simplifying and streamlining quality compliance to the utmost. ISO 13485 quality management is the cornerstone of what we do – because no other enterprise-level regulation can claim to be the global gold standard for the medical device industry.

By introducing our expertise alongside your own, it becomes possible to deliver on even the most ambitious program of medical device commercialization. Instead of a nigh-insurmountable hurdle to progress, each phase becomes part of a cohesive journey toward brand differentiation built on world-class quality. There is simply no better mark of your tireless focus on customer outcomes.

At the same time, it becomes far easier to scale your business and drive international expansion. With ISO 13485 compliance bolstered by strategic business and engineering expertise, your enterprise can adjust and adapt to new market requirements in a fraction of the time. That alone translates to defining competitive advantages in time-to-market.

ISO 13485 can empower you with greater efficiency, flexibility, and cost-effectiveness. The sooner you implement adherence, the sooner these benefits will accrue – over time, they grow into institutional assets that potential competitors will be hard-pressed to overcome.

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