Frameworks like ISO 13485, ISO 27001, and ISO 9001 are essential for managing clinical risks, data security, and supplier quality — especially when working with the NHS, global regulators, or international distribution networks.
AvISO has supported clinical diagnostics firms, medical device manufacturers, and healthtech companies to implement ISO 13485, ISO 27001, and ISO 9001. Our consultants have also helped organisations align with MHRA, EU MDR, FDA, and GDPR requirements.
This sector faces high-stakes challenges: safeguarding sensitive personal data, ensuring clinical and manufacturing quality, and complying with an evolving landscape of international regulations.
From maintaining sterile production and device traceability to managing AI in diagnostics, healthcare organisations must juggle multiple frameworks — often under pressure from regulators, funders, and insurers. Failing to comply can mean delayed launches, legal risk, or reputational damage.
An integrated, standards-based approach is essential for demonstrating compliance, protecting patients, and enabling innovation in a controlled and auditable way.
AvISO understands the strict, multi-framework environment in which healthcare and life sciences organisations operate. We support clients from early-stage startups to global providers in building systems that align with ISO standards while integrating regulatory, ethical, and operational controls.
We help map clinical and operational processes to ISO requirements, identifying overlaps and streamlining documentation. Whether supporting NHS frameworks, CE marking, or international compliance, we deliver systems that reduce duplication and improve risk management.
ISOvA Toolbox gives your team visibility across compliance activities — from data privacy logs and clinical audits to CAPA records and document updates — all in one secure platform.
We provide tailored training in ISO 13485, internal audits, GDPR, QMS best practices, and incident response — designed for clinical, regulatory, and administrative teams. Support is available on-site or remotely, depending on your needs and regulatory timelines.
Clece Care Services comprises a network of 20 regional care companies. With a presence in 100 locations throughout the UK and a workforce exceeding 7,000 care and support professionals. AvISO are supporting them across all locations within the UK with implementing and maintaining their ISO Standards certification across five Standards, we also supported them to extend the scope of their ISO 45001 system across all subsidiaries and roll out Cyber Essentials Certification.
ISO 13485 – Medical Devices Quality Management
Required for manufacturers of medical devices, diagnostics, and components. Supports risk-based quality management, design control, and traceability — aligning with MDR, IVDR, and FDA expectations.
ISO 27001 – Information Security Management
Protects sensitive patient data, clinical research, and health records. Supports GDPR compliance, cybersecurity policies, and safe management of cloud-based platforms and healthtech systems.
Used widely across healthcare service providers, laboratories, and biotech firms. Helps streamline processes, document control, and continuous improvement of service delivery or R&D.
ISO 22301 – Business Continuity Management
Ensures essential health services, supply chains, and clinical operations continue during disruption — including pandemics, cyberattacks, or supplier failure.
ISO 14001 – Environmental Management
Addresses environmental impact in manufacturing, disposal of clinical waste, sustainable packaging, and ESG reporting — particularly in pharma and biotech.
ISO 27701 – Privacy Information Management
An extension to ISO 27001 that enhances governance of personal health data, supporting data subject rights and regulatory alignment.
ISO 42001 – Artificial Intelligence Management
AI is increasingly used in diagnostics, drug discovery, and patient care tools. ISO 42001 provides a framework for ethical, transparent, and secure AI deployment — particularly relevant to organisations using machine learning in clinical pathways or healthtech platforms.
In regulated sectors, compliance can become overwhelming — fast. At AvISO, we cut through the complexity, designing ISO systems that are clear, relevant, and manageable for internal teams, auditors, and regulators alike.
We help you embed compliance without stalling innovation or adding excessive burden.
With patient care and product safety at the centre, compliance must be reliable, accessible, and scalable. AvISO and ISOvA deliver just that — combining consultancy with intuitive compliance software.
Whether you’re launching a device, scaling a platform, or improving systems, we help keep you compliant — and focused on care.
Beyond core ISO standards, AvISO supports:
Our consultants bring sector knowledge and regulatory insight to help you maintain trust, safety, and operational control.
If you would like to know more about ISO Standards, Certification and the value of a good management system you can add to your business we would love to hear from you: Kent: 01892 800476 | London: 02037 458 476 | info@avisoconsultancy.co.uk
