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Life Sciences Regulations: Understanding ISO & FDA Compliance

Posted 21 May 2024

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The life sciences industry is subject to complex regulations designed to ensure the safety, efficacy and quality of medical devices, drugs and other products. Regulations vary depending on the specific product and the geographic market, but they all share the common goal of protecting public health. Understanding and complying with these regulations is essential for any company operating in the life sciences sector.


Table of Contents:

Life Sciences Regulations: Importance of ISO & FDA Compliance

There are two key regulatory frameworks that impact most life sciences companies: ISO standards and FDA regulations.

  • ISO (International Organization for Standardization) is an international body that publishes standards for a wide range of industries, including life sciences. ISO 13485 is the most relevant standard for medical devices, and it outlines the requirements for a quality management system (QMS) that helps ensure the consistent design, development, production, installation and servicing of medical devices.
  • FDA (U.S. Food and Drug Administration) is the regulatory agency responsible for ensuring the safety and effectiveness of drugs and medical devices in the United States. The FDA publishes a vast array of regulations, but one of the most important for life sciences companies is 21 CFR Part 820, which outlines the Quality System Regulation (QSR) for medical devices.

Compliance with ISO and FDA regulations demonstrates a company’s commitment to quality and patient safety. It can also be a requirement for doing business in certain markets and for obtaining marketing authorisation for new products.

Understanding FDA Regulations

The FDA enforces a comprehensive set of regulations for life sciences companies, but 21 CFR Part 820, the Quality System Regulation (QSR), is particularly relevant. This regulation outlines the requirements for a QMS that ensures the design, manufacture, and distribution of safe and effective medical devices.

Key Requirements & Compliance Standards

21 CFR Part 820 outlines a series of requirements for a medical device QMS, including:

  • Establishment registration and listing
  • Quality control procedures
  • Design controls
  • Production and process controls
  • Labelling and packaging controls
  • Post-market surveillance

Companies must demonstrate that their QMS meets these requirements through documented procedures, training programmes, and recordkeeping.

ISO 13485: Understanding The Standard

ISO 13485 is an international standard that specifies the requirements for a quality management system (QMS) for medical devices. It is designed to help organisations ensure the consistent design, development, production, installation and servicing of medical devices that meet customer and regulatory requirements.

Introduction to ISO 13485

ISO 13485 is a risk-based standard that requires companies to identify and manage the risks associated with their medical devices. The standard also emphasises the importance of continuous improvement and the need to demonstrate that the QMS is effective in meeting its objectives.

Scope & Application in Life Sciences Industry

ISO 13485 applies to all organisations involved in the lifecycle of a medical device, from manufacturers and distributors to contract manufacturers and sterilisation service providers. While not mandatory in all markets, achieving ISO 13485 certification demonstrates a company’s commitment to quality and can be a valuable asset for companies seeking to do business internationally.

Bridging ISO 13485 & FDA 21 CFR Part 820

There is a significant degree of harmonisation between ISO 13485 and FDA 21 CFR Part 820. Both standards emphasise the importance of a quality management system, risk management and process control. By complying with ISO 13485, companies can be well on their way to meeting the requirements of FDA regulations.

Strategies for Ensuring Compliance with Both Standards

Here are some key strategies for ensuring compliance with both ISO 13485 and FDA 21 CFR Part 820:

  • Develop a comprehensive QMS that meets the requirements of both standards. This will help to avoid duplication of effort and ensure that your company is meeting all applicable regulatory requirements.
  • Conduct a gap analysis to identify any gaps between your existing QMS and the requirements of the standards. This will help you to prioritise your compliance efforts.
  • Develop and implement corrective and preventive actions (CAPA) to address any identified gaps. This will help you to continuously improve your QMS and ensure its effectiveness.
  • Maintain a robust document control system to ensure that all procedures, records and other documentation are accurate, up to date and readily available.
  • Provide adequate training to your employees on the requirements of the standards and your company’s QMS procedures.
  • Conduct regular internal audits to assess the effectiveness of your QMS and identify any areas for improvement.

Compliance Challenges & Solutions

Common Challenges in Achieving ISO & FDA Compliance

Despite the benefits, achieving and maintaining compliance with ISO and FDA regulations can be challenging. Here are some common hurdles:

  • Complexity of the regulations: Both ISO 13485 and FDA regulations are complex and can be difficult to interpret.
  • Resource limitations: Implementing and maintaining a compliant QMS can be resource-intensive, especially for small companies.
  • Keeping up with changes: Regulatory requirements can change frequently, so companies need to stay up to date on the latest developments.

Best Practices and Solutions for Overcoming Compliance Hurdles

Here are some best practices to help companies overcome these challenges:

  • Seek professional guidance: There are many consultants and advisors who can help companies understand and comply with ISO and FDA regulations.
  • Invest in quality management software: Software can help companies to automate many compliance tasks, such as document control and training management.
  • Develop a culture of quality: A strong commitment to quality from senior management is essential for successful compliance.
  • Participate in industry associations: Industry associations can provide valuable resources and support for companies working to comply with regulations.


Localising Content While Accounting for Regulatory Requirements

Life sciences companies face another challenge when venturing into international markets: localisation. Simply translating content isn’t enough. You must adapt it to adhere to the specific regulations and cultural nuances of the target market. This is where linguists with in-market expertise come into play by ensuring the translated content complies with the target market’s regulations.

This prevents costly delays, product recalls and even legal issues further down the line. But compliance goes beyond just regulations. Translators must also have an awareness of the specific terminology used in the target region. The term “bandage” in the US might be “dressing” in the UK, and both terms could have regulatory implications. Even seemingly simple things like units of measurement or colour associations can have unintended consequences.

Closing Thoughts

Achieving compliance with ISO and FDA standards is essential for any company operating in the life sciences industry. By understanding the requirements, developing a robust QMS and implementing best practices, companies can ensure the safety and efficacy of their products and achieve their business goals.

For expert life sciences translation services that ensure regulatory compliance and clear communication across languages, look no further than ALM Translations.

ALM Translations is a trusted partner for life sciences companies around the world. With a team of specialist translators and a proven track record of success, ALM can help you to translate your regulatory documents, clinical trial materials, and other life sciences content into multiple languages while ensuring accuracy, consistency and compliance with relevant regulations.

Request a free quote today to learn more about how ALM Translations can help you achieve your life sciences compliance goals.

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