Let us unravel your COMPLIANCE issues
Call us for a free no obligation quote on 07774 857622
MDC can handle your Adverse Incidents and communications to the relevant Regulatory bodies including Vigilance Reporting on your behalf.
PRODUCT AND SYSTEM STANDARDS
We can offer and advise you on the interpretation and use of International, European and Country specific standards.
PRODUCT REGULATORY ASSESSMENT
Ensure that your product complies with relevant legislation prior to product launch. MDC can assess your product to ensure compliance.
THIRD PARTY TESTING
Need to test your product but not sure what to test? How and where to do it? We can identify test criteria and co-ordinate on your behalf.
Nobody wants to have to do one. Let us carry out the recall or field correction on your behalf effectively and efficiently.
CE MARKING AND TECHNICAL FILE COMPLIANCE
You concentrate on designing and developing your products and leave the CE marking to us. We can ensure that you meet the Essential Requirements of the Medical Devices Directive 93/42/EEC and have a comprehensive technical file to support it.
POST MARKET SURVEILLANCE
The most effective but often not utilised way to improve your products. We can analyse your business data that is often ignored and identify product and design deficiencies, barriers to sale, quickly and easily.
EU AUTHORISED REPRESENTATIVE
Do you want to import and sell a medical device in the EU and have somebody take the regulatory responsibility for the product? As a registered authorised representative we can act on your behalf.
PRODUCT LIABILITY CLAIMS
Our experience of liability claims can help you with any issues that come your way. Let us assist in those claims that often seem an impossible to win situation.
ADVISORY CAPACITY ON EC DIRECTIVES, UK STATUTES, CONTRACTUAL ISSUES ETC
Legislation can be complicated. MDC can help you decipher and understand that complicated piece of legislation.
NEW PRODUCT DEVELOPMENT AND PRODUCT INTEGRATION
Launching a product correctly, on time and fully compliant is key to any business. Get it wrong and you can endure painful times correcting any issues. MDC can guide you through a specifically tailored process that can cover up to 120 areas from financial justification through to product launch with tha addition of a monitoring period to act upon customer feedback post launch.
Time and money can be saved by making the easiest and most subtle changes to the way we work. Let us audit your processes and drive efficiencies that can save more than you thought.
Avoid those costly mistakes during production. look at where you can potentially fall foul and produce a load of scrap components or finished items. Our experience can help ensure it doesn’t happen to you.
A radical approach can help to overcome those issues that we are often exposed to.
PRODUCT LIFE CYCLE ANALYSIS
It is important to identify the durability of your products to enable you to determine a realistic warranty period, frequency of planned preventative maintenance and how long a product will last.
Building supplier relationships and in turn optimising supplier performance is a key part of supply chain management. Allow us to appraise and evaluate suppliers on your behalf.
We can audit your internal processes as part of your quality management system.
QUALITY TOOLS (SPC, PFMEA, DFMEA, RISK ANALYSIS, QFD)
Maintain control of your process. Continual monitoring is more cost effective than reactive costs of rework, repairs or recalls.
It is often easy to overlook key areas of a product that may cause concerns later. We can offer an evaluation service that will review functionality, performance, ergonomics, labelling, risk of misuse etc.
KPI’S (KEY PERFORMANCE INDICATORS)
How successful is your organisation? How do you measure performance? We can help you put meaningful measures in place to effectively monitor performance and progress.
COST OF QUALITY
How much does quality cost your business? With the use of a proven formula that utilises failure, appraisal and prevention costs we can show you how to determine cost of quality and target cost savings by addressing inefficiencies.
Whether you want a complete environmental management system or to implement policies and processes to reduce waste and promote recycling. Substantial cost savings can be made by promoting awareness and using a ‘green’ approach.
Time spent dealing with customer complaints can be a huge drain on resources. We can remove the burden and resolve them on your behalf.
Meet those specific project goals and objectives by adopting the discipline of planning, organising, securing and managing resources. We can offer that independent support to managing those projects regardless of size.
CUSTOMER/SUPPLIER VISITS AND AUDITS
Utilise our years of extensive customer liaisons to act on your behalf. Does your supplier manage current processes? Do they verify what they supply? We can audit on your behalf and identify any shortcomings before they affect your business.
Publications need to be accurate and concise regardless of format. Allow us to do that time consuming job of proof reading your user, service or maintenance manuals.
DUE DILIGENCE (ACQUISITIONS)
Thinking of expanding by way of acquisitions? We can offer support in quality, regulatory, technical and manufacturing functions.