Let us first understand why QMS (Quality Management System) is so important. Though QMS is important for any industry but for Pharmaceuticals and Medical devices it is like heart of system.
Compliance is the key to medical device, therefore understanding the regulations in various area and countries and then making your documentation to cover that part effectively. ISO 14385 is general ISO standard, but it tells that you need to follow each countries regulation in letter and spirit. Like, CFR part 820 for USA, MDR for European union and CDSCO for India.
Another part is monitoring changes and accordingly updating your documentation so system must be strong, and all concerned member should understand easily and follow.
A quality management system (QMS) contains all that internal teams, partners, and regulators alike need to know to get a product to market and achieve its planned purpose of delivering enhanced outcomes to clinicians and patients. The selections you make around the QMS you decide to implement will resonate throughout your product’s lifespan.
- Account for medical device regulatory requirements
The regulatory process for medical devices is comprehensiblyinflexible. Regulators have the significant task of making sure every device that is sold in the market is safe, harmless and effective for its end users. For your device to join those ranks, you will need to recognise which regulatory requirements will apply and integrate those processes into your QMS to assure compliance. This should be an ongoing concern throughout the entire lifecycle of your medical device. ISO 13485 recommends risk management approach and separate standard is available (ISO 14971) risk assessment for medical devices. Each system you choose and write documentation for your medical device need to be justified through risk management. Regulators would like to see that you have understood risk and mitigated to maximum possible extent.
DO: Determine the applicable regulations for your medical device. Like mentioned above USA, European union etc.
DON’T: Underestimate the role of regulatory changes and compliance. As mentioned above changes are part of your life and each time it must be dealt effectively.
- Decide if you will take a legacy or modern approach
A legacy system is ad hoc in nature and uses general-purpose tools, like physical paper (just like it sounds), digital paper (Excel/Word), and document loading (SharePoint/Dropbox). They are perceived as a low-cost, low-effort QMS solution, but are known for being cumbersome and difficult to manage as a company scale. Now decision depends on your scale of operation and whatever system you follow control requirements are same. Manual system may pose many challenges of error which can be an issue for the company.
A modern QMS solution is a software-based system that is purpose built to address the specific needs of its users and their niche market. These have built in controls and many other systems which will not allow you to make errors.
DO: Consider the total costs of a QMS solution. This decision will be busines decision.
DON’T: Compromise quality for the sake of cost
- Assure traceability that enables a closed-loop medical device QMS
A closed-loop quality system is one that connects the technology, people, and processes across all phases of the total product lifecycle (TPLC) from beginning to end. This type of system permits you to respond to issues in real-time and proactively monitor and mitigate risk, while also enabling full traceability amongst your product growth and quality events. Built in controls, proactive actions, warnings, reminders, are jobs of software so once you partly customise to your device your job becomes easy.
DO: Fully integrate design controls, risk management and quality events
DON’T: Let disconnected systems affect your ability to scale. It should not be mechanical standalone system but disconnected so you may then have to look for update etc.
- Assess QMS software solutions
In a niche vertical, such as the medical device industry, the complex nature of the quality and regulatory landscapes makes finding the right solution a hefty task for device makers. For companies taking a modern approach with a QMS software solution, it is important to assess the software provider and the industries it serves. Professionalism and expertise of software provider is important so when we talk of medical device then software provider understand that, and our feeding will be specific to our product and customisation. Infect, software provider should be able to enhance our approach.
DO:Choose a purpose-built solution
DON’T: Overlook implementation and validation efforts associated with general-purpose QMS solution. These are compulsory and regulatory requirement.
- Partner with medical device industry experts
The medical device industry is experiencing a tsunami of regulatory changes in response to the emergence of new technologies. Previously known best practices are being replaced by more well-organized approaches, and new practises are being tested in every facet of the industry. A shrewd constructer knows to pay close attention to all of them.
DO: Choose a partner with a proven track record of success
DON’T: Underestimate the value of staying ahead of regulatory changes. As stated above software provider should be proactive in this area.
