Home » Services » Compliance Essentials

Compliance Essentials

Stay compliant with confidence through ongoing expert regulatory and quality support. Compliance Essentials provides flexible monthly consultancy to help medical device, IVD and digital health organisations maintain compliance, manage regulatory changes, support their Quality Management System and meet post-market obligations without the cost of a full-time regulatory team.

500+ Manufacturers Supported

BSI ISO 13485 Certified

UK & EU Offices

Former MHRA Expertise

Established 2017

Why Choose Compliance Essentials?

Achieving regulatory compliance is only the beginning. Medical device, IVD and digital health organisations must continually maintain their Quality Management System, monitor regulatory changes, update technical documentation, manage post-market activities and respond to customer, auditor and regulatory requirements. Without ongoing expert support, maintaining compliance can quickly become resource-intensive and increase the risk of non-conformities.

Compliance Essentials is Patient Guard’s flexible ongoing compliance support service, providing access to experienced regulatory and quality professionals without the cost of employing a full-time in-house team. Whether you need occasional expert advice or comprehensive outsourced regulatory support, our monthly packages help you stay compliant, minimise regulatory risk and focus on growing your business with confidence.

David Small - Patient Guard - CEO and Founder

"Regulatory compliance isn't a one-time achievement—it's an ongoing commitment. As regulations evolve, products change and post-market obligations increase, organisations need access to experienced regulatory and quality expertise they can rely on. Compliance Essentials provides flexible, practical support to help businesses maintain compliance, reduce regulatory risk and focus on innovation rather than administration."

David Small BSc (Hons), MSc, MTOPRA

Founder and CEO

Why Choose Patient Guard?

Ongoing regulatory expertise

Gain access to experienced regulatory and quality professionals whenever you need them, without the cost and commitment of employing a full-time in-house team.

Flexible monthly support

Choose the level of support that suits your organisation, with scalable monthly packages designed to grow alongside your business and changing compliance needs.

Proactive compliance management

We help you stay ahead of regulatory changes, maintain compliance and address issues before they become costly problems or impact your business.

Established regulatory consultancy

Providing specialist regulatory affairs, quality assurance and digital health compliance services to the healthcare industry since 2017.

Trusted by 500+ companies

From innovative start-ups to global manufacturers, organisations trust Patient Guard to provide practical regulatory and quality support throughout the entire product lifecycle.

Supporting your entire product lifecycle

Whether you need help maintaining your Quality Management System, updating technical documentation, managing post-market activities or preparing for audits, we're here to support your organisation every step of the way.

What's Included in Compliance Essentials

Regulatory & Quality Advice

Access experienced regulatory and quality professionals whenever you need guidance on compliance, product changes, regulatory strategy or quality management.

Technical Documentation Support

Receive ongoing assistance maintaining your Technical Documentation, Clinical Evaluation, Performance Evaluation, Biological Evaluation, Risk Management and other regulatory files.

Quality Management System Support

Keep your Quality Management System effective with expert support for ISO 13485 documentation, process improvements, audits, CAPAs and continual compliance activities.

Post-Market Compliance

We help you manage ongoing post-market obligations, including PMS, PMCF, PMPF, vigilance activities, trend reporting and regulatory updates throughout your product lifecycle.

Regulatory Change Management

Stay ahead of changing regulations and standards with practical advice on new requirements, helping you implement changes efficiently while maintaining compliance.

Dedicated Ongoing Support

Your organisation benefits from direct access to experienced consultants who understand your products and business, providing responsive, practical support whenever you need it.

Who Can Benefit from Compliance Essentials?

Medical device, IVD and digital health manufacturers requiring ongoing regulatory and quality support.
Organisations without an in-house regulatory or quality team that need flexible access to experienced consultants.
Companies maintaining ISO 13485, EU MDR, UK MDR, IVDR or FDA compliance throughout the product lifecycle.
Businesses requiring support with Technical Documentation, Clinical Evaluation, Risk Management and post-market activities.
Manufacturers preparing for audits, inspections, product changes or evolving regulatory requirements.

Key Areas We Support

Maintaining compliance doesn’t stop once you’ve achieved DTAC readiness. Compliance Essentials provides ongoing support to help digital health organisations maintain compliance, respond to evolving NHS requirements and ensure their products remain procurement-ready throughout their lifecycle.

Ongoing DTAC compliance across the five DTAC domains.
Clinical Safety support, including DCB0129, DCB0160 and Clinical Risk Management.
Cyber security and technical assurance guidance to support NHS expectations.
Preparation for NHS procurement, supplier assurance activities and ongoing compliance reviews.
Information Governance, Data Protection and NHS policy updates.

How Compliance Essentials Works

Initial Onboarding & Review

We get to know your organisation, products and current compliance status.

Ongoing Expert Support

Receive flexible monthly consultancy, regulatory advice and documentation support tailored to your needs.

Continuous Compliance Improvement

We help you respond to regulatory changes, prepare for audits and maintain long-term compliance.

Digital Health Technologies We Support

Organisation Type	How Our DTAC Readiness Assessment Helps
Digital Health Start-ups	Understand NHS requirements before engaging with customers or procurement frameworks.
Scale-up Health Technology Companies	Identify compliance gaps before expanding into NHS markets.
Software as a Medical Device Manufacturers	Align DTAC readiness with regulatory and clinical safety obligations.
Medical Device Manufacturers with Digital Products	Prepare connected devices and companion software for NHS adoption.
AI Healthcare Developers	Demonstrate governance, safety and compliance to NHS buyers.
NHS Suppliers	Strengthen evidence before responding to tenders or framework opportunities.
Healthcare Software Vendors	Assess readiness against all DTAC domains and prioritise improvements.
International Companies Entering the UK	Understand NHS procurement expectations and prepare supporting evidence.

Choose the Right Compliance Essentials Package

Feature	Compliance Essentials Lite	Compliance Essentials Plus ⭐ Most Popular	Compliance Essentials Premium
Monthly Fee	£350 + VAT	£850 + VAT	£2,000 + VAT
Included Consultancy	Up to 2 hours/month	Up to 6 hours/month	Up to 16 hours/month
Regulatory Advice	✓	✓	✓
Email & Telephone Support	✓	✓	✓
DTAC Compliance Support	✓	✓	✓
Clinical Safety Support (DCB0129 & DCB0160)	✓	✓	✓
Documentation Reviews	✓	✓	✓
Policy & Procedure Support	—	✓	✓
Information Governance Support	—	✓	✓
Cyber Security Guidance	—	✓	✓
Procurement Readiness Support	—	✓	✓
Monthly Compliance Review	—	✓	✓
Priority Response Times	—	✓	✓
Strategic Compliance Planning	—	—	✓
Dedicated Regulatory Consultant	—	—	✓
Unlimited Email Support*	—	—	✓
Audit & Assessment Preparation	—	—	✓
Ongoing Regulatory Intelligence	—	—	✓
Quarterly Compliance Health Check	—	—	✓

Time Lines

Step 1 – Onboarding & Compliance Review

We begin by understanding your organisation, digital health technologies and current DTAC compliance position. Together, we'll identify priorities and agree a tailored support plan that aligns with your business objectives.

Step 2 – Ongoing Expert Support

Your organisation receives flexible monthly access to experienced consultants for regulatory advice, DTAC guidance, clinical safety, information governance, cyber security, documentation reviews and procurement readiness support.

Step 3 – Continuous Compliance Improvement

As your organisation evolves, we help you maintain compliance, respond to NHS and regulatory changes, prepare for audits and supplier assurance activities, and ensure you remain procurement-ready throughout the product lifecycle.

Frequently Asked Questions (FAQs)

1. What is Compliance Essentials?

Compliance Essentials is Patient Guard's ongoing monthly compliance support service for digital health organisations. It provides flexible access to experienced consultants who can help you maintain DTAC compliance, support clinical safety activities, respond to regulatory changes and remain procurement-ready throughout your product's lifecycle.

2. Who is Compliance Essentials designed for?

Compliance Essentials is ideal for digital health companies, Software as a Medical Device (SaMD) developers, healthcare technology providers and organisations supplying products or services to the NHS. It is particularly valuable for businesses that do not have a dedicated in-house regulatory or compliance team.

3. What types of support are included?

Depending on your chosen package, Compliance Essentials can include DTAC guidance, clinical safety support (including DCB0129 and DCB0160), documentation reviews, information governance advice, cyber security guidance, procurement readiness support, regulatory updates and ongoing access to experienced compliance consultants.

4. Can I upgrade or change my package?

Yes. As your organisation grows or your compliance requirements change, you can move between Compliance Essentials packages. This allows you to increase your level of support without committing to a completely new consultancy project.

5. Why choose Compliance Essentials instead of hiring an in-house compliance team?

Compliance Essentials gives you access to a multidisciplinary team of experienced digital health, regulatory and clinical safety specialists for a predictable monthly fee. This provides expert support whenever you need it, without the cost and overhead of recruiting, training and retaining a full-time in-house compliance function.

Related Services

Click on the links below to discover more:

Do you need Training?

Check out Patient Guards Training Courses

Recent Blog Posts

Cosmetic Product Safety Report (CPSR): A Complete Guide to UK Cosmetic Compliance

August 31, 2026 No Comments

Before a cosmetic product can legally be placed on the UK market, manufacturers and Responsible Persons must demonstrate that it is safe for human use under normal or reasonably foreseeable conditions. The Cosmetic Product Safety Report (CPSR) is one of the most important regulatory documents required under the UK Cosmetics Regulation. This guide explains what a CPSR is, who can prepare one, what information it must contain, how it relates to the Product Information File (PIF) and how it supports legal cosmetic compliance.

IVDR PMPF Explained: A Complete Guide to Post-Market Performance Follow-up

August 24, 2026 No Comments

Post-Market Performance Follow-up (PMPF) is a fundamental requirement under the EU In Vitro Diagnostic Regulation (IVDR), ensuring that manufacturers continually monitor the scientific validity, analytical performance and clinical performance of their in vitro diagnostic medical devices after CE marking. This guide explains IVDR PMPF requirements, PMPF Plans, PMPF Reports, Annex XIII expectations and how ongoing performance monitoring supports continued regulatory compliance throughout the device lifecycle.

IVDR Scientific Validity Explained: A Complete Guide for Manufacturers

August 17, 2026 No Comments

Scientific Validity is the first pillar of IVDR Performance Evaluation and provides the scientific foundation demonstrating that an analyte or biomarker is associated with a specific clinical condition or physiological state. This guide explains Scientific Validity under Regulation (EU) 2017/746, including literature reviews, Scientific Validity Reports, Annex XIII requirements, evidence appraisal and how Scientific Validity supports successful CE marking.

IVDR Performance Evaluation Explained image for Patient Guards blog on IVDR Performance Evaluation

IVDR Performance Evaluation Explained: A Complete Guide for Manufacturers

August 10, 2026 No Comments

Performance Evaluation is one of the most important requirements under the EU In Vitro Diagnostic Regulation (IVDR). Every manufacturer must demonstrate that their in vitro diagnostic medical device achieves its intended purpose through robust scientific validity, analytical performance and clinical performance evidence. This guide explains every stage of IVDR Performance Evaluation, including Performance Evaluation Plans (PEPs), Performance Evaluation Reports (PERs), Post-Market Performance Follow-up (PMPF) and how Performance Evaluation supports successful CE marking under Regulation (EU) 2017/746.

IVDR Classification Explained: A Complete Guide to Class A, B, C and D IVDs

August 3, 2026 No Comments

Understanding how your in vitro diagnostic device is classified under the EU IVDR is one of the first and most important steps towards regulatory compliance. This guide explains the IVDR classification rules, the differences between Class A, B, C and D IVDs, how Annex VIII is applied, and how classification affects conformity assessment, technical documentation and Notified Body involvement.

When Do You Need New Biocompatibility Testing for a Medical Device?

July 27, 2026 No Comments

A material change, supplier switch, manufacturing transfer or design modification does not automatically require new ISO 10993 biocompatibility testing. Learn how manufacturers use Biological Evaluation Plans (BEPs), chemical characterisation, toxicological risk assessments and Biological Evaluation Reports (BERs) to determine whether existing biological evidence remains valid or whether additional testing is required under ISO 10993-1, the EU MDR and FDA expectations.

      
   Patient Guard Ltd
   9 Google reviews 
  Write a review 
 
 
 
   
 
 
      Posted on Google  
   
   Munna P 
 52 days ago
 
 
 Trustindex verifies that the original source of the review is Google. Working with the Patient Guard team has been a great experience throughout our MHRA and ISO 13485 documentation journey. Their expertise, structured approach, and practical guidance helped our team build a robust quality management system while keeping us aligned with regulatory expectations. The collaboration was professional, responsive, and focused on finding solutions rather than simply identifying issues. A special thank you to Alex and Steve for their outstanding coordination, responsiveness, and continuous support throughout the project. They were always approachable, provided valuable feedback, and worked closely with our team to resolve challenges efficiently. Their commitment made a significant difference in keeping our documentation effort on track. I highly recommend Patient Guard to any healthcare or MedTech organization looking for experienced regulatory and quality system partners for MHRA, ISO 13485, and broader medical device compliance initiatives. Thank you again to the entire Patient Guard team for being such reliable partners.
  
 
     Posted on Google  
   
   Peter Reeve 
 79 days ago
 
 
 Trustindex verifies that the original source of the review is Google. STEPPER design, manufacture & distribute eyewear across the globe.  With the increasingly complex landscape concerning the placing of Mecial Devices onto the market, we realised we needed professional guidance. We found Patient Guard via a simple internet search and are delighted we did! They provide a pragmatic solution to our needs, are totally reliable & always available to answer our (often simplistic) questions. They are highly efficient & responsive to what is a changing picture in our world and nothing is too much trouble. We have a much better understanding of regulatory affairs and our responsibilities as manufacturers & distributors and they support us in navigating the requirements in different territories. Updating our Declaration of Conformity, ensuring our labelling is compliant and acting as our PRRC are the key areas of their service for us.
  
 
     Posted on Google  
   
   Derek Timm 
 79 days ago
 
 
 Trustindex verifies that the original source of the review is Google. For those companıes lookıng to comply to ISO standards and ın partıcular ISO13485 whıch to be honest ıs a nıghtmare I would strongly suggest goıng to the professıonals as ındeed we dıd by joınıng forces wıth Patıent Guard Ltd   The staff are fantastıc  nothıng ıs too much trouble and as a medıcal supply company we sımply cannot lıve wıthout them  Thanks ın partıcular to Alex and Steve for all the hard work and our best regards from Dan Medıca South Lımıted
  
 
     Posted on Google  
   
   BMSCriticalCare 
 116 days ago
 
 
 Trustindex verifies that the original source of the review is Google. Great service, very helpful and always willing to answer any questions we have,
  
 
     Posted on Google  
   
   Thomson Software 
 787 days ago
 
 
 Trustindex verifies that the original source of the review is Google. Alex Lewis of PatientGuard guided us through the ISO13485 process in a thorough, systematic and efficient manner.  He was friendly, patient and willing to go the extra mile.  Excellent service.
  
 
 
  
 
   Verified by Trustindex  Trustindex verified badge is the Universal Symbol of Trust. Only the greatest companies can get the verified badge who has a review score above 4.5, based on customer reviews over the past 12 months. Read more