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.   Medical Device Regulatory Support To us at Majakel Medical, it’s the people that make all the difference. Our highly motivated and experienced medical device consultants support our clients at all stages along with iso 13485, 21 cfr part 820 of the relationship including;   Quality System Development Gap Assessment System Development Internal Audit Mock Audit Supplier Audit   Design Lifecycle Software and Hardware Development Project Planning Requirements Definition Specification Development Risk Management Traceability Design Review   Product and Process Development Prototyping Manufacturing Logistics Verification Validation   Submissions Support   Contact...

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Outsourcing: Manufacturing, Documents and People

Electronics Sub-Contract Manufacture to ISO 13485 Does your device have embedded electronics hardware? Then our strategic partner can provide a comprehensive assembly and test service, all within a tried and tested ISO 13485, ISO 9001 and AS9000 environment.   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 capability. Staffed at all levels by personnel with extensive experience in medical device manufacturing; this facility will offer our customers significant benefits in both cost and control.   Training Records Management Using our QMS software we can support your training management requirements to ensure: Supplier Internal / External Audit Programs Complaint Handling and Adverse Event Reporting Electronic Document Change Control   Contact...

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Medical Device Verification and Validation Service

Majakel Medical’s consultants provide all aspects of healthcare device consultancy along with iso 13485, 21 cfr part 820, verification & validation. 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 our medical device consultants 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. This could involve developing the Project Plan, identifying Resource Allocations, creating the Master Validation Plan, performing Risk Assessments, IQ, OQ, PQ, and all reports. If you are developing a product then let us support you through all parts of the development and manufacturing lifecycle:- Master Validation Plan development and reporting Process optimization using Design of Experiments including response surface and Taguchi IQ/OQ/PQ Protocol development, implementation and reporting Measurement Systems Analysis including Gage R&R studies and Attribute Agreement Capability studies and Statistical Process Control Re-validation events and machine moves If you are designing or procuring an automated process then we can also perform software qualification through GAMP5. Examples of equipment and processes that we have successfully validated: Laser, Resistance and Ultrasonic welding Hydroxyapatite Robotic Plasma Spraying Adhesive Bonding using Cyanoacrylate, two part Epoxy, UV curable, RTV CNC Machining, Turning and Grinding centres Automated Packaging systems including blister and pouch Process test equipment including; Leak Blow and Dye penetration High Voltage Continuity Automated labelling systems Automated vision inspection systems Robotic assembly systems Compression and Silicon moulding   Contact...

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Healthcare Product Development

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 which range from; CAD/CAM Design and Modelling Tooling Design Electronics Design Software Design Project Management Quality Engineering Regulatory Human Factors Manufacturing Engineering Operations Supplier Development If your product development process involves any of the following activities then we can support you with training, evaluation and implementation; Initial concept for design and process Project Management Regulatory route to market Risk Management for the system including Software Clinical Evaluation 510K submission, MDD approval Product Design and Development Quality and Process Engineering to support design and development Validation and Verification of design, product and process, iso 13485, 21 cfr part 820 Process Development, Engineering Builds, Manufacturing, Automation, Testing Packaging and Sterilisation Shipping and Logistics   Contact...

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