Quality: Regulatory, Systems and Engineering
Quality is a cornerstone of any regulated industry and requires a high level of understanding of the subject in order to deliver solutions that are suitable for the size of the company, its products and its people. At Majakel Medical we pride ourselves on being able to provide support throughout the full spectrum of quality activities which are relevant to any industry.
To us at Majakel Medical, it’s quality people that make all the difference. Our highly motivated and experienced medical device consultants support our clients at all stages of the relationship including ISO 13485, 21 CFR part 820, verification & validation, Medical Device Regulatory Support etc.
Outsourcing: Manufacturing, Documents and People
Disposable Device Manufacturing – COMING SOON. Get in early and book a slot within our new medical device manufacturing facility, including class 8 clean room and ISO 13485 approval. Staffed at all levels by personnel with extensive experience in medical device manufacturing, this facility will offer our customers a significant benefit in cost and control.
Verification and Validation is one of our specialty offerings, from single process optimisation and qualification through to complete product development, we can tailor a solution to suit. Whether your product is hardware, software or process we have the skills and experience to ensure that our solutions are robust, safe and cost effective.
Talk to us about our Managed Validation Program – whether it is moving equipment or even relocating site then let us take the risk out of your move by providing a comprehensive validation service. Tailored to your requirements, costs and timescales, we can plan and execute the activity through all stages.
Through our own expertise and having access to a number of experienced medical system design consultants we can offer a comprehensive design and development package tailored to suit. No matter which phase of development you are in we can provide a solution that is cost effective, responsive and tuned to your needs.
All of our consultants have a minimum of 5 years experience in their chosen discipline.