BCS Clinical Consulting

Independent regulatory consulting to the medical device, software as a medical device, medical apps and digital health sector

What do we do?

Who we work with...

We provide independent contract consulting services to organisations who design, produce, manufacture, supply or deploy and use any of the following:

  • Software as a medical device (SaMD).
  • Medical apps.
  • Medical devices of all types with a particular focus on 'active' devices and in vitro diagnostic (IVD) medical devices with software components or accessories.
  • All types of health software, NHS IT systems and digital health systems, eg. electronic patient records; medications prescribing, administration and management;  laboratory information systems; A&E and triage systems; patient monitoring and alerting software (real-time, acute, remote, telehealth);  mental health and social care information systems; patient administration systems; clinician to patient communication systems; and patient aids.
  • Messaging systems, middleware, pairing integration and interoperability systems;
  • Clinical decision support and health analytical software.
  • Artificial Intelligence (AI), deep learning, machine learning, big data algorithms.
  • Software as a Service (SaaS) within the healthcare sector.
  • Health software based on health informatics, information standards, datasets and structured clinical terminologies (eg. SNOMED CT) and coding (Read, dm+d, OPCS4, ICD-10, NHS Data Dictionary), DICOM standard, HL7 messaging and bar-coding standards including AIDC/RFID.
  • Electronic medical equipment/medtech.
  • Laboratory equipment.
  • Virtual reality software for healthcare;
  • Bio-technologies/bio-tech.

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:

  • Health and social care providers and organisations providing regulated clinical services.
  • Health and social care standards developers.
  • Auditors and regulators - both within the clinical / healthcare sector and the medical devices and digital health sectors.

Services we provide...

Regulatory, quality and expert consultancy services offered include:

  • Complete regulatory projects from definition of regulatory strategy to product certification and registration.
  • Development of bespoke Quality Management Systems (QMS) compliant to all required regulations and standards depending on organisation, product and/or service type, classification, intended market and route to market.
  • Acting in the role of "suitably qualified" Quality Officer, Regulatory Affairs Officer and/or Safety Officer.
  • Full range of NHS Digital Accredited Clinical Safety Officer (CSO) services including development of DCB0129/SCCI0129 and DCB0160/SCCI0160 compliant clinical safety management systems, conducting hazard assessments, writing clinical safety case reports, providing clinical safety authorisation to release and being your named, appointed accredited CSO.
  • Medical device risk management projects, including hazard analysis and risk management reporting.
  • Preparation of medical device Technical Files/Device Master Records for Notified Body audit or FDA inspection - all classes of device.
  • Organisation readiness for stage 1 and 2 Notified Body quality and standards audits and certifications.
  • Post market clinical follow up (PMCF) reports, clinical evaluation reports (CERs) and incident management / corrective action preventative action (CAPA) reporting.
  • Gap analysis prior to or remedial action following Notified Body audit or FDA inspection.
  • Gap analysis between existing EU Medical Device Directives and new EU Medical Device Regulations.
  • Virtual and Contract Manufacturing consultancy (formerly known as Own Brand Labelling (OBL) and Original Equipment Manufacturer (OEM), including supplier evaluation and definition of contractual quality agreements.
  • 21 CFR 11 compliance (electronic records and electronic signatures).
  • Information governance and data protection consultancy - organisational policy and procedure and individual software product compliance.
  • Training, competence and awareness in all aspects of medical device regulation and clinical safety.  
  • Standard or bespoke training at your organisation can be provided, eg. DCB0129/SCCI0129 or DCB0160/SCCI0160 training.
  • Standards appraisal and assurance.

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.

Compliance we achieve...

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:

  • CE marking and product safety EU Directives.
  • Competent Authority (eg. MHRA) registration.
  • Medical Device Directive 93/42/EEC, In Vitro Diagnostic Medical Device Directive 8/79/EC and Active Implantable Medical Devices Directive 90/385/EEC compliance.
  • EU Regulation on Medical Devices (MDR) 2017/745 and EU Regulation on In Vitro Diagnostic Medical Devices (IVDMDR) 2017/746 compliance.
  • Food & Drug Administration (FDA) approval.
  • Therapeutic Goods Administration (TGA) approval and registration.
  • ISO 13485 (medical devices quality management systems).
  • 21 CFR 820 (quality system regulations).
  • ISO 9001 (quality management - general)
  • ISO 14971 (medical devices risk management).
  • DCB0129/SCCI0129 and DCB0160/SCCI0160 (NHS health IT clinical safety).
  • IEC 62304 (medical device software development lifecycle).
  • IEC 60601-1 (medical electrical equipment safety).
  • IEC 62366 (medical device usability engineering).
  • ISO 15233 (medical device symbols and labelling).
  • ISO 27001 (information security management systems).
  • NHS Information Governance Toolkit (IGTK) compliance.
  • General Data Protection Regulation (GDPR) compliance.
  • HIPAA & HITECH compliance.
  • ISO 20000 (ITIL / service management).
  • ISO 22301 (business continuity).
  • Support with NHS Apps Library accreditation, in particular clinical safety and information governance.
  • NHS Digital clinical safety authorisation to release / pairing integration.
  • Support with GPSoC accreditation.
  • FDA submissions including Pre-Submissions, 510k, De Novo and Pre Market Approval (PMA) applications.
  • Medical device clinical trial and ethics applications (MHRA/HRA Notice of No Objection).
  • Care Quality Commission (CQC) standards implementation, gap analysis and audit readiness.

If you would prefer to define your own procedures, we can also license our own QMS document templates for you to tailor and implement.

Who are we?

Small, dedicated, cost effective and personal

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.

Experienced, qualified and competent

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.

Successful partnerships

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:

  • Academic Health Science Networks
  • Acurable
  • Anabasis
  • Biolacuna
  • BioMe
  • BMJ
  • Caristo Diagnostics
  • CSC
  • Data Standards Assurance Service
  • Department of Health
  • Drayson Health
  • Drayson Technologies (Europe) Ltd
  • DrEd
  • EMIS Health
  • Global Innovation Forum
  • Healthcare Gateway
  • Healthera
  • Health & Social Care Information Centre
  • Health Online
  • Information Standards Assurance Service
  • Informatica Systems
  • InVent
  • iSOFT
  • Mendelian
  • Mologic
  • MRC Technology
  • NHS Connecting for Health
  • NHS Digital
  • Oxford Biodesign
  • Oxford University Hospitals
  • Oxford University Innovation
  • Oxford Virtual Reality
  • PlaqueChecker
  • Quality Health
  • Skin Analytics
  • ThinkShield
  • Tiny Medical Apps
  • Ufonia
  • Ultromics
  • University of Oxford

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Contact Us

If you have a question, a project you would like to speak to us about or you want a completely free of charge assessment of your regulatory needs, get in touch...

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For booked appointments, plenty of local parking is available nearby.

BCS Clinical Consulting Limited

43 Mill Street, Clowne, Chesterfield, Derbyshire S43 4JN, England, United Kingdom

07928 153601 / 01246 570170 bscott@bcsclinicalconsulting.com

Hours

Mon

09:00 – 18:00

Tue

09:00 – 18:00

Wed

09:00 – 18:00

Thu

09:00 – 18:00

Fri

09:00 – 18:00

Sat

Closed

Sun

Closed

We close on bank holidays.