Independent regulatory consulting to the medical device, software as a medical device, medical apps and digital health sector
We provide independent contract consulting services to organisations who design, produce, manufacture, supply or deploy and use any of the following:
Although no project is too big or too small, we have a particular specialty in advising start-ups, university spin-outs, pre-investment research projects, smaller organisations, branching out of pharma organisations into the medical device sector and existing medical device manufacturers into the software as a medical device sector. Our aim to is create flexible, cost effective regulatory strategies and projects, enabling you to get through the complex regulatory process and get your product out to market as soon and as safely as possible.
Because regulations and standards are what we do, in addition to the manufacturing and supply sector, we also provide our regulatory, clinical governance and patient safety consultancy services to:
Regulatory, quality and expert consultancy services offered include:
We can also work closely with you and your organisation to procure, set up and/or configure internal electronic tools to meet the required regulatory requirements for management of digital documents, records and electronic signatures and also to support product and software development lifecycles, workflows, controls and approvals; whether you work Agile or more traditionally.
If you need to become compliant to any of the following regulations, standards, certifications and accreditations, we can implement or support a single or combined project to achieve compliance on your behalf:
If you would prefer to define your own procedures, we can also license our own QMS document templates for you to tailor and implement.
BCS Clinical Consulting Ltd was founded as an independent consulting agency by Beverley Scott in 2011, after a successful professional career working as a registered nurse, clinical safety officer and regulatory affairs practitioner in the NHS digital health and software as a medical device sector.
We are a small but expert and dedicated company who know how to work smart and want to create direct relationships with our clients. We are passionate about the future of technology and healthcare, but equally so about patient safety and standards. You will always know who is working on your project, be assured of their professional credentials and be in direct and regular contact with them. Your project and goals are important to us and will not get lost in a large complex, commercially driven organisation.
Our overall aim is that you experience all the benefits of having an extra expert team member on board, but without the costly overhead and risk of employing a whole time equivalent or using recruitment agencies. When you agree to work with us, we will be on hand to offer advice and assistance whenever you need it and you can engage with us in a formal way or a more ad hoc, flexible way to suit you, your project and your budget.
Over the years, we have refined our internal approach, systems and tools so that we are able to take on multiple clients and projects and be effective to you without taking up large amounts of your critical resource. We offer ad hoc consultancy, retainer contracts, fixed prices services, contract accredited clinical safety officer service, entire projects and anything else in between.
Between us, we have over 40 years of clinical, regulatory, quality and patient safety experience to offer you; with a focus on the digital health and medical devices sector. Our consultants are registered healthcare professionals, experienced, qualified and accredited health IT clinical safety officers (NHS CSO) and medical device quality assurance / regulatory affairs (QA/RA) officers.
We have extensive experience working for and with the NHS health IT regulator (NHS Digital), commercial health IT suppliers and numerous medical device and medical app manufacturers. We thoroughly understand the NHS, UK, EU, US and wider global regulatory landscape for digital health and the med-tech industry; in particular, the merging of health software into the regulated medical device industry and the concepts of standalone software as a medical device (SaMD) and software as an accessory to in vitro diagnostic (IVD) medical devices.
We know exactly what is required to get through the complex regulations (whether your product qualifies as a medical device or not) and translate the existing (physical) medical device essential requirements into requirements for software as a medical device. We also know how to address the increasing laws and regulations on data privacy, data sharing, processing and storing, managing data assets, anonymisation rules, consent, data protection, information security and information governance alongside.
Our particular skill is in defining a single operating lifecycle for any size of organisation, with an underpinning quality management system designed to meet all the required regulations and standards in a phased approach. This means that you learn and evolve as a regulated company with our support; adopting procedures in a gradual way as they integrate seamlessly into your business as usual practices, rather than creating costly and disparate bolt on systems and procedures which rarely pass audit.
We have a 100% successful track record in meeting our clients' requirements, with many staying on post project or coming back to us for repeat or retainer services.
Clients we have worked with include:
To make an appointment or request a call back, please get in touch using the form.
For booked appointments, plenty of local parking is available nearby.
43 Mill Street, Clowne, Chesterfield, Derbyshire S43 4JN, England, United Kingdom
09:00 – 18:00
09:00 – 18:00
09:00 – 18:00
09:00 – 18:00
09:00 – 18:00
We close on bank holidays.