QUALITY MANAGEMENT CONSULTANTS BASED IN SCOTLAND
SUPPORTING START-UPS AND ESTABLISHED COMPANIES ACROSS THE UK AND INTERNATIONALLY
Our team, at SJ MedTech Consultants, has over 30 years' expertise in the Medical Device Industry.
We support all manner of businesses, from small start-ups to large, well-established companies. Our quality management consultants based in Scotland will assist you in implementing the required documentation and processes to achieve ISO 13485 and ISO 9001 certification or ensure re-certification. We can also help you successfully establish your warehouse and logistics processes. With over three decades of experience in the industry, we have assisted businesses across the world, including in the UK, US & Africa, in establishing and improving their QMS, manufacturing and logistics processes, ensuring adherence to ISO 9001 & 13485 requirements.
AIM HIGH, FROM A FIRM FOUNDATION
We will support you in building out your company's processes, to ensure your success.
Contact us through our Enquiries page, on 07934 149 152 or by email at now.
OUR SERVICES
We offer a one-stop shop, as quality management consultants, based in Scotland. We can provide a remote or on-site service based on your requirements. Our QMS implementation processes ensure that your business is established in compliance with all legal requirements and put you in excellent standing to achieve ISO 9001 and ISO 13485 certification and re-certification.
Visit our Services page to learn more about what we can do to establish your business processes effectively.
THE PROCESS
1. Make an Enquiry
First things first – get in contact. Call us on 07934 149 152 to make that enquiry and discuss your business. We'll talk about what you're aiming to achieve and see how our services can place you in good stead to make that happen.
2. Gap Analysis/Risk Assessment
Before any systems audits can take place, we must perform comprehensive gap analyses and risk assessments of your business. As your quality management consultants, we'll examine your systems and processes, before presenting a report. These will cover the risks inherent in your model, as well as areas which can be improved.
3. Implementations and Improvements
Once the gap analysis and risk assessment processes are complete, we'll get to work. Drawing on over three decades of experience in the medical devices industry, we'll implement the changes we have agreed together, readying you to achieve official certification and validation from the relevant governing bodies.
3.5. Warehouse Facility Implementation (Where Required)
If you're an established business, your company will, in all likelihood, have an operational warehouse facility already in place. For start-ups, looking to get their foot in the door, your quality management consultants based in Edinburgh can help you establish these facilities and ensure their compliance with regulations. For established businesses we can also help to build out and improve your current processes.
4. Final Audits
Once your new systems have been implemented and established, the relevant professional body will perform a full site audit. This will ensure the effective compliance of your systems and processes and enable you to function in the most operative capacity. Your systems will be validated, certified and you'll be ready for business.
