In the highly-regulated world of medical device manufacturing, organisations have a duty to show that every device meets both customer expectations and applicable regulations. Lloyd’s Register (LR) supports clients in their efforts to meet the stringent requirements of ISO 13485, fine-tuning product development lifecycles to ensure a timely market launch.
The international quality management system (QMS) standard for medical devices, ISO 13485:2016 (Medical Devices – Quality management systems – Requirements for regulatory purposes) was published 1 March 2016 and introduces a host of subtle, yet detailed, changes requiring more thorough documentation on the work environment, risk management, design control and regulatory requirements. The revised standard includes the need for a risk-based approach to the QMS, an enhanced focus on regulatory requirements and the responsibilities of top management, increased controls over suppliers and outsourced activities, and an emphasis on risk management throughout the product lifecycle.
ISO 13485 applies to both manufacturers of medical devices and organisations that support medical device manufacturers. It underpins the manufacturers’ duty of ensuring devices consistently meet customer and applicable regulatory requirements.
Remote audits provide you with a fast and flexible way to maintain your audit schedule. They help reduce carbon footprint associated with travel, as well as health and safety risks for people working on hazardous sites or hard to reach areas. Outcomes are consistent with onsite audits, so the integrity of your audit and accredited certification remains the same.
Why is it important to your organisation?
A pathway to regulatory compliance
The primary objective of ISO 13485 is to facilitate harmonised medical device regulatory requirements for quality management systems and It already forms the basis of the MDSAP.
A commitment to quality and potential safety
Patient safety depends on the quality of medical products. ISO 13485 certification gives manufacturers confidence that organisations throughout the supply chain can achieve and maintain compliance with regulatory requirements. This demonstrates a strong commitment to quality and assurance of patient safety.
A proactive approach to risk management
ISO 13485 emphasises the importance of risk management throughout the entire product lifecycle. Taking this into account, certification is a confirmation that an organisation takes proactive and effective steps to prevent incidents and minimise risk. This demonstrates that patient safety is a priority and helps to minimise the risk of reputational damage to manufacturers caused by product defects.
Need help with ISO 13485?
As the internationally recognised standard in the world of medical device manufacturing, ISO 13485 helps you beat the competition by minimising risks throughout your product development lifecycle.
Thanks to LR’s systematic approach, you will receive the appropriate support at every stage of product development facilitating a timely market launch.
Why work with us?
Dedication to assurance
LR explores every quality management system process with rigorous, analytical precision to draw accurate conclusions every time.
LR is accredited by United Kingdom Accreditation Service (UKAS) we are an authorised MDSAP Auditing Organisation for the Australian Therapeutic Goods Administration (TGA), the Brazilian Health Surveillance Agency ( ANVISA), the Canadian Health Products and Food Branch (Health Canada, the United States Food and Drug Administration (FDA) and the Japan Ministry of Health, Labour and Welfare and Japanese Pharmaceuticals and Medical Devices Agent (MHLW/PMDA).
Our auditors are industry specialists whom we match with your business needs, enabling an effective audit of your QMS that drives positive short and long-term impacts.
Your business helps LR to help others
The profits we generate fund the Lloyd’s Register Foundation, a charity which supports science and engineering-related research, education and public engagement around everything we do. All of this helps us stand by the purpose that drives us every single day: Working together for a safer world.
Who we work with
We help businesses across dozens of sectors push forward and achieve like never before. How can we help you?
Putting the patient first at Penlon.
Putting the patient first. Auditor training to transition to the latest ISO quality management system standard for medical devices. See how in our case study.