Our Services at Corporate Control
- Assessments of Quality Management Systems within companies who are going for certification or maintaining certification under European ISO Standards.
- Assessments of Quality Management Systems for companies who need to adhere to the regulation requirements for the USA, FDA.
- Our specialities are in European Standards for ISO 9001, ISO 13485 (Medical Devices) and USA - FDA regulations under 21CFR Part 820.
- Product document assessments for CE Marking, 510k submissions (USA).
- Project Management of Validation activities in Process, Production Manufacturing and Facilities to reduce validation timelines which will qualify process lines / products more quickly and so reduce company costs.
- Validation Documentation support: writing, reviewing of documents (Validation, Standard Operating Procedures, Work Instructions).
- Training in requirements for all the above indicated activities dependant on company requirements.
What our client's say about us.
“Through my own activities within the medical device industry I have had direct dealings with Corporate Control on a number of occasions. The company's principle, Dennis Burns, is both extremely competent and fastidiously thorough in his approach. My experience with the company spans more than a decade and over this period I have witnessed it's involvement in many different disciplines across the industry. Corporate Control display an equally high level of ability in expediting 'hands-on' project based work, and providing more general expertise in fields such as Quality Management Systems and Risk Management.
I have no hesitation in wholeheartedly recommending Corporate Control. If you are looking for a company that will provide the highest level of service and add value to an individual project or your organisation, then look no further. Corporate Control and it's associates will provide knowledge, reliability and commitment where ever you need it.”
