With a wealth of experience from a background in industry and government (our Director started her career with the MHRA), we approach medical device regulations from a business view point. If a device cannot be brought to the market profitably then no patient can benefit. Equally, if the device harms patients, the caregivers will seek alternatives. We enjoy finding the balance and applying the same regulations to different products and often in different ways.
We have a lot of experience of assisting companies prepare their technical documentation; with external body audits and with implementing action plans. We love to create strategies, but we can also be hands-on if you require. Get in touch via the contacts page and let us know how we can help.