Hire the Best ISO 9001 Specialists
in the United Kingdom

I transform concepts or prototypes into manufacturable designs ready for market. I have 30 years of delivering consumer products, car interiors and even medical devices for clients and my own company. I prioritise speed to market, development cost, or product cost according to your commercial needs. Services I offer: • Design for Manufacture (DFM) • SolidWorks and KiCAD supplier build packs • Materials and manufacturing process selection • Costed bills of materials and realistic production cost targets • Mechanical–electronics integration and packaging • Assembly strategy and tolerance resolution • Supplier identification and manufacturing planning • Preparation for CE/UKCA testing and regulated environments • Trouble shooting any technical or commercial aspect of product development I can bridge between early prototypes and production with in-house 3D printing, laser cutting, assembly including specialist processes: cleanroom; low humidity; plasma surface treatment; freeze-drying; vacuum packaging. I have verified prototype and low-volume partners for injection moulding, CNC machining, pcb manufacture. I have particular expertise in development of in-vitro-diagnostic (IVD) medical devices, from concept to production, from initial concept design through rapid design-build-test cycles leveraging my in-house prototyping facilities and testing laboratory, If you are developing a physical product and need help turning a concept or prototype into a manufacturable design, feel free to get in touch. As a fellow entrepreneur, I understand sometimes you are looking for specialist advice to supplement your in-house team, for example to trouble shoot, manage a difficult supplier, decide strategic direction, or even to evaluate alternative funding routes.For this I offer direct consultation sessions on an hourly basis.

Need a GDPR-compliant privacy policy or clear, watertight data processing agreements and policies? I help businesses simplify compliance and protect their reputation with easy-to-understand, business-ready documents. Services I provide: Custom GDPR/UK Data Protection policies & cookie notices Customised Data processing & sharing agreements Review or drafting of Non-disclosure agreements (NDAs) & SaaS contracts Subject Access Request (SAR) support Compliance toolkits & staff training Why me? ✔ LLM. Data Protection & Intellectual Property (Distinction) – specialised in Data Protection & IP ✔ Westin Scholar Award from International Privacy Professionals Association ✔ 3+ years’ experience as a Compliance/Privacy Specialist ✔ Skilled at turning legal jargon into practical solutions Let’s work together to make compliance clear, simple, and effective. Message me today to get started!

We write policies, SOPs and any technical documents for your team, including digital forensics teams, cyber security and quality management departments. With a quick turnaround in just a few days, we help labs SOCs and security specialists turn complex regulatory requirements into documents your team need and use. We’re passionate about what we do and proud to support teams who need clear, reliable documentation that actually works in practice. We’re discreet, security cleared and trusted to work on sensitive projects. You take the credit — we’re here to give you that boost towards your next promotion or accreditation milestone. What We Do: We know the challenges teams face: too many documents to write, confusing standards, and not enough time or in-house resources to get it done. That’s where we step in. * We draft, review and update documentation so you don’t have to * We simplify complex standards into clear, practical policies * We close gaps before they become audit findings * We bring consistency across teams and systems * We create documents that new staff can pick up and use straight away Our Experience: We’ve project managed cybersecurity work for SMEs, law enforcement and the private sector, creating documentation from scratch — even where no policies or procedures existed before. Our approach is collaborative: we arrange fact-finding interviews and meetings to make sure we capture everything you need in the document. This ensures your processes are accurately represented and easy for your team to follow. Why Work With Us: * Security cleared and ready to visit your team onsite * Fast response times and open communication * Projects completed with time to spare * Documents that work in the office and lab In a Nutshell: We’re not just writers, we’re partners in helping you meet your deadlines, close compliance gaps and keep your documentation practical and professional.

Hello, I am Tracy, and I love training and reading! Although I have over 30 years of corporate training under my belt, I am also an accomplished editor. I have trained many people in many subjects using my own courseware. I will also edit your work and check for misspellings, punctuation, and inconsistencies. I will also edit and correct issues at the core of your writing, such as sentence construction and language clarity. I am an expert in SEO, Microsoft Office, Excel, Word, Zotero and Endnote. I am confident in my skills and dedicate 100% to each job. My motivation is to pass my passion onto each client’s work so that the finished product is professional and great! What I do: Training: HR, Soft Skills and Business English Editing: SEO Articles, Blog Articles, Human Resource policy documents, Research proposals for both undergraduate and postgraduate and General corporate documents

GRC, GDPR & Compliance Consultant | ISO | Audit Readiness Profile overview I assist regulated and quality-led organisations turn complex governance, risk and compliance requirements into practical, audit-ready systems. As a senior GRC and compliance consultant, I advise boards, executives and cross-functional teams on compliance maturity, regulatory exposure, control effectiveness and remediation priorities. My approach combines risk-based assurance, evidence review, root-cause analysis and clear executive reporting—giving leadership a defensible view of risk and a realistic path to improvement. I will assist your organisation with: - GRC framework and operating-model design - Compliance gap assessments and maturity reviews - Audit, certification and inspection readiness - Policies, procedures and internal controls - Risk registers, control testing and assurance trails - CAPA, root-cause analysis and remediation oversight - Supplier governance and supplier-control improvement - QMS design, implementation and transformation - Board, audit committee and executive reporting - GDPR governance and operational compliance support - ISO 27001-aligned information-security governance My sector experience includes MedTech, Software as a Medical Device (SaMD), SaaS. legal, law firms and other highly regulated or standards-led environments. I understand how quality, privacy, information security, software lifecycle controls and enterprise risk must work together—not as disconnected compliance exercises. Standards and frameworks within my experience include ISO 13485, MDSAP, ISO 14971, IEC 62304, FDA 21 CFR Part 820, ISO 9001, ISO 14001, ISO 45001, ISO 27001, ISO 17065, LEXCEL and UKDIATF. Clients engage me when they need an independent senior perspective, practical remediation support or stronger evidence before an audit, certification assessment, customer review or regulatory inspection. If you need a compliance framework that works in practice and withstands scrutiny, let’s discuss your current risks, deadlines and desired outcome. *Governance, Risk Management & Compliance *Regulatory Compliance *GDPR *Compliance Consulting *Risk Assessment *Internal Auditing *Professional Services Code of Conduct - legal *Information Security *Quality Management System *Policy Development *Audit *Risk Management *Process Improvement *Medical Device *Corrective and Preventive Action Independent Governance, Risk & Compliance Consultant UK, EU and global engagements. Advise senior leaders on GRC operating models, compliance maturity, audit exposure and regulatory readiness. Conduct independent assurance and audit-readiness reviews to identify control gaps, weak evidence and systemic risks. Translate regulatory and standards requirements into practical policies, procedures, controls and ownership models. Design and improve management systems aligned with international ISO and sector-specific standards. Stabilise CAPA, supplier-control, risk-management and audit-remediation programmes. Produce executive reporting that supports informed risk and compliance decisions.

Enthusiastic and aspiring Biomedical Engineer with more than 4 years of experience in the medical device industry working on regulatory submissions for various medical devices (Neurostimulators, HIFU systems, ultrasound diathermy, smartwatches) and submitted for US FDA, EU MDR, Health Canada and so on. Experience in drafting quality SOPs as per ISO 13485 and product documentation for Software as a Medical Device (SaMD) as per IEC 62304. Hands-on experience with IEC 60601 and ISO 14971 standards. Working on various SaMD projects (AI/ML algorithm-based software) for regulatory submissions. Working on drafting Denovo Submission for Kelvin-PD (SaMD), technical documentation for MDR 2017/745/EU and drafting technical documents such as software documents, Product Description, Labelling. Hands-on Experience with ISO 13485:2016 external audit with BSI for recertification. Hands-on Experience on software validation for tools such as Adobe Acrobat Signature for computerized systems validation. Expertise in the transition from ISO 27001:2013 to ISO 27001:2022 and proven record on achieving certification with no non-conformances. Successfully completed the entire QMS starting from building to implementation as per ISO 13485:2016 without non-conformities and established a good relationship with Notified body BSI.