Your first regulatory worry, ahead of CE-marking, comes during the device R&D stage when you must ensure your development processes and subsequent manufacturing follow the quality requirements and specifications set out in the international standard of practice.
Helene Lamielle, MD, MBA has been working in clinical, regulatory, R&D and strategic development for medical devices for the past 28 years and, more recently, she has been consulting startups on their R&D strategy, organisational development and investment options in Orange County, California.
“A common concern is that quality system management entails putting barriers or constraints on the creativity and the development of ideas,” Lamielle says, “so sometimes R&D people or even management are concerned about it being implemented too early.”
A quality system, according to Lamielle, will help set out what needs to be done from a development and manufacturing perspective. It aims to answer questions like ‘What is your device’s purpose?’ and ‘What do you want to accomplish with it?’. It’s implementing some sanity checks on whether or not it matches the company’s expectations from the outset.
“When you have a targeted product profile in place, with its intended use and target population, you then start to build the paperwork, encouraging your company staff to write SOPs related to their respective functions. You need to update the system with all your key people, from development, to HR, manufacturing, regulatory and marketing.”
An up-to-date quality system will ensure you receive an ISO 13845 certification and the earlier this is done the more it helps the company stick to its initial development plan and keep itself on track, Lamielle believes.
First things first: start working on a quality manual. This is where you define your company’s mission. It should be very straightforward in terms of information: talk about what your company does, what the management does, how the company is staffed, how the product will be designed, how it will be validated and verified, and the strategy for entering into the target market.
Next, list the Standards of Practice that support the functioning of your company – from product development and design control, to risk management and human resource management.
“A quality management system is like your company’s internal vertebral axis. You don’t submit it but it will be reviewed at the time of an audit by Notified Bodies. It’s an internal tool for the company that is carefully reviewed by the regulatory agencies to make sure that you have developed according to the standards of practice,” Lamielle explains.
There is a global harmonisation on the standards of practice, so a QMS should cover you in major markets like Europe, the US, Canada and Australia, however there are some additional elements to follow if you’re targeting some Asian countries, like China and Japan, for example.
The classical mistakes startups make is to do either too much work or too little for their QMS.
“When you hire an expert to help you put together your quality manual – which you should unless you have senior employees familiar with the exercise – they will be very much aware of what needs to be done for you to become perfectly compliant. The pitfall may be to embark on much more work than necessary, according to the stage your company is at,” Lamielle says. “You want the company to be helped by the QMS, not to be in the business of building a QMS.”
You need to be in tune with your QMS consultant’s approach to certification. Sit down and have a thorough discussion about which standards of practice they think you need to follow according to your type of device. The key here is not the more standards you comply with the better, but which standards are most crucial for your device at this stage for your company.
The ideal time to get the ISO certification is probably around the time you start your first-in-human validation, according to Lamielle. “The quality system needs to develop with the company, it should not be artificially imposed too early on with extensive constraints that don’t add value. You need to own and believe in the value of your QMS and related SOPs, because you have to demonstrate continuous compliance with them”
Alternatively, you can make the mistake of not doing enough for your QMS and future certifications. Allowing your development team to carry on work without the necessary documentations and critical steps in place will make it very difficult and time intensive to reconstruct your paperwork in the wake of an audit. You will miss the added value of a good QMS and the critical and pertinent questions it raises for management and for the various functional teams. You will also miss the discipline of keeping track on logic and reality checks on what the company intends to achieve.
Building up the QMS documentation is a necessary compliance requirement, but should also be regarded as a critical and useful tool that assists in development efforts. This is why it’s vital to strike the right balance in terms of timing and the content that goes into it.
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