Things to keep in mind for 2023!
We expect many developments within our field of expertise for 2023. These are the main developments of which we are certain that they will impact you. In this blogpost we will briefly explain what changes will occur, how this will impact you, and how we can help you handle them. You can expect more detailed […]
Risk Management Medical Devices
Recently the Health Care and Youth Post Inspectorate brought out a post regarding electric wheelchairs. In the article the importance of having a good Risk Management system in place was illustrated, along with showing how a product with low risk does not mean it is without risk. To add onto this, the Post also elaborated […]
A Complete Guide to Medical Device Certification and Compliance in the European Union and the United Kingdom
In the European Union and the United Kingdom, there are specific regulatory and legal perimeters that apply to the manufacturing and distribution of medical devices. We have developed this comprehensive guide to assist manufacturers who are either based in these regions or who plan to sell their medical device products on either of these markets.
An A-Z Guide to Medical Device Regulations in the United Kingdom
In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating medical devices. Since January 2021, there have been a number of changes when it comes to regulating medical products in the UK, and this article is intended to provide an easy-to-follow guide for ensuring your product meets the correct requirements.
Medical Devices – What Does the Future Hold For Compliance?
KPMG Advisory stated in April 2021: “While the outlook for medical device companies appears positive, unsustainable healthcare costs and new competitive forces threaten to alter the future industry landscape…” The medical device industry is a fast-growing, lucrative industry however, are product manufacturers able to keep up? With many new regulations and evolving legislation for products globally, medical device manufacturers must act now to ensure the viability and longevity of their products into the future.
Certifying Medical Devices in the United States – Here’s What You Should Know
Medical devices cover a wide range of products – from robot-assisted surgical instruments to a bandage or gauze. The spectrum of medical device classification is wide and it is extremely important to know which classification your product falls under. In the United States, there are both mandatory and voluntary certification procedures when it comes to ensuring compliance with your medical device. We have outlined the key requirements for your business here.