Complete Regulatory Affairs & Quality Assurance Services and Consultancy
Medical-DeviceZ (Med-DevZ) Ltd helps clients place safe and effective medical devices on to the market first time around, with patient safety and wellness being at the forefront. We take on all your medical device compliance needs, leaving you only to focus on the Sales and Business Growth!
- Trusted
- Experienced
- Professional
Services
What We Do...
With over 15 years of experience in the Medical Device and Pharmaceutical Industry, we understand the importance of Compliance and route to market across the Globe!
UKCA, MDSAP, & CE Certification
Whether it is maintenance of your current products to EU MDD 93/42/EEC, or you are looking to transition to the new EU MDR 2017/745 we are able to assist with all the complexities of the changes!
Full support for UK and Overseas manufacturers with UKCA marking if marketing into the United Kingdom.
Selling Globally, then MDSAP may be the answer with one Single Audit!
Technical Documentation
Producing a Medical Device is no simple process. The Device must be supported with comprehensive documentation, backed with clinical and sound scientific data to ensure the products are safe and effective to pass the scrutiny of Notified Bodies!
We can assist with both building the Technical Documentation for you, or performing a gap analysis so your RA/QA teams can meet the requirements.
Quality Management Systems (QMS)
Every manufacturer must work to a specified industry standard to ensure a certain level of Quality, this does not need to be, but is most commonly achieved by compliance to ISO13485 for Medical Devices.
We can build a full system either fully document based, or to complement with your QMS Software (such as Q-Pulse / Agile).
As Lead Auditors we can perform audits of your systems such as ISO13485, ISO14971, and MDD /MDR Certifications to help before the vital Notified or Customer Audits!
Why WE STAND OUT
Project Management
Delivering Projects on time is key to attaining Certification and Market Approval.
(We are IPMA (International Project Management Association) Certified).
Business Support
We understand that Business can not stop, so we support around your day to day business activities!
(We have real life industry experience from design concept, to product launch and surveillance).
Global Reach
We work Globally, and have knowledge of Product Registrations for different markets around the world, to help you sell into new countries.
(We can liaise directly with Authorised Representatives in each market).
