Service 1
UK Responsible Person for Medical Devices
From 1st January 2021, any medical device manufacturer based outside the UK will need to designate a UK Responsible Person that is established in the UK.
At Bowline Consulting we have extensive experience of managing all aspects of medical device regulation and can offer fully compliant UK Responsible Person services tailored to your product portfolio at competitive rates. We can retain and manage the technical documentation and ensure full independence and neutrality. We can manage your incident and market surveillance obligations in the territory and support your interaction with the Competent Authority.
Finally, we can support registration of your portfolio of products with the MHRA and implementation of UKCA marking.
Service 2
Legal and regulatory Services specialising in Pharmaceutical, medical and medical device industries.
Legal and regulatory expertise within the Pharmaceutical and Medical Device sectors. Broad experience in dealing with all UK regulatory and certificating bodies and expert knowledge of the applicable legislation. We can support the smallest start-ups through to international corporations at whatever stage of the journey you are at. After many years of inspections and working for companies of all sizes, we have the experience and expertise needed to help your company and ensure that it is ready for upcoming inspections. Not only do we provide one-off help we can also provide ongoing support for your company. We can support start-up companies with assessing licencing requirements and strategies, support you through the application and inspection processes and help develop appropriate procedures and systems to ensure ongoing compliance. We can help established businesses with improved compliance, help respond to non-conformances and develop systems to promote awareness and buy-in across the organisation. Finally, we can support business development projects, advising on regulatory strategies and optimisation of resources and investment.
Service 3
Quality Management systems.
We provide expertise to help your company conform to a variety of common quality management systems, such as GDP, ISO9001:2015 and ISO13485:2016. No two companies are the same, so it is important that your Quality Management System accurately reflects how your business works and what it does. We do not use templates but take a ground up approach to help create systems that ensure complete alignment between the standard and your business. If you operate to multiple standards we can help you develop integrated systems compliant with all. We can update you existing systems or start from scratch.
Service 4
Process Design & measurement
All businesses collect data, many don’t use this invaluable resource to drive sales, profit and efficiency. We can review your data and overlay that with an assessment of key processes and activities within the business to identify those data sets that truly indicate the health of your business, in addition looking for gaps in the available data. We can look at how data can be used to inform and support key business decisions and to accurately track the effectiveness of implementation. We can support you in developing ways to make information and feedback more measurable and useful to the business.
