Watch

The founder on the method, in two minutes

About the founder and the method.

The pattern that started this business: good companies paying for quality systems that made their work slower and stopped being used within a year.

How the consulting works

Meet the founder

Ishan Maharaj, Founder and Principal Consultant

ISO Cloud Consulting was founded by Ishan Maharaj, an industrial engineer who has spent his career in regulated medical device manufacturing, moving from engineering and planning roles into senior operations and quality leadership. The templates and courses on this site come from building and running quality systems that had to pass real audits, not from theory.

ISO 13485 and medical device experience

  • Design, qualification and validation of controlled manufacturing environments, including cleanrooms and the utilities that support them.
  • ISO 13485 quality management systems, ISO 14971 risk management and technical documentation for regulated markets.
  • Capital and expansion projects, from facility design through validation planning.
  • Supplier and technology evaluation, process validation, and the link between quality records and ERP, logistics and warehouse systems.

ISO 9001 and quality management

  • ISO 13485 is built on the ISO 9001 process model, and the core disciplines (process approach, risk-based thinking, internal audit, corrective action, management review) are applied daily in a certified medical device QMS.
  • Wrote the ISO 9001:2026 template library and courses on this site, checked clause by clause against the published standard.
  • Background in lean management, process design and operational improvement from industrial engineering practice.
What We Do

Specialist Medical Device Quality and Regulatory Support

We help medical device companies build, improve, and remediate systems that need to stand up to certification, customer, and regulatory scrutiny.

Our core areas of support

• ISO 13485 Quality Management Systems
• ISO 14971 Risk Management
• Internal Audit Programs
• CAPA System Improvement
• Design Controls and DHF Support
• Supplier Quality and Purchasing Controls
• Sterilization and Process Validation
• Audit Remediation and Gap Closure

We do not build paper systems.

We build practical, audit-ready systems that are structured to work in real medical device businesses.

That means clear ownership, usable procedures, linked records, traceability across processes, and documentation that supports how your business actually operates.

Whether you are building from scratch or fixing a system under pressure, the goal is the same: a system that holds up when reviewed properly.

Who We Work With

We support:

  • Medical device startups building their first QMS
  • Growing companies preparing for ISO 13485 certification
  • Established manufacturers fixing audit findings
  • QA/RA teams needing specialist support
  • Companies expanding into new regulatory markets

Whether you are building from scratch or fixing a failing system, the objective is the same —a system that holds up under scrutiny.

Explore the Areas We Support

If you already know where the pressure is in your system, start with the most relevant service area below.

ISO 13485 Consulting

Build, improve, or remediate your medical device quality management system.

ISO 14971 Risk Management

Risk files, hazard analysis, control measures, and residual risk evaluation.

Internal Audit Support

Risk-based audit planning, execution support, findings, reporting, and follow-up.

CAPA System Improvement

Root cause, action planning, effectiveness checks, and closure discipline.

Design Controls and DHF

Design planning, inputs, outputs, verification, validation, and file structure.

Supplier Quality

Supplier evaluation, approval, monitoring, purchasing controls, and performance review.

Sterilization Validation

Validation structure, routine control, requalification, and validation package remediation.

QMS Setup

Structured QMS build for startups and growing medical device businesses.
Frequently Asked Questions

Questions We’re Often Asked

If you are evaluating ISO Cloud Consulting for medical device quality or regulatory support, these are some of the questions clients usually ask before getting started.

What does ISO Cloud Consulting do?
We help medical device companies build, remediate, and strengthen quality management and regulatory systems. Our work typically covers ISO 13485 implementation, internal audits, CAPA remediation, risk management, design controls, documentation systems, supplier controls, training support, and practical audit readiness. We also sell online ISO 9001:2026 and ISO 13485 courses with certificates of completion, and editable templates.
Who do you work with?
We work with medical device startups, growing manufacturers, established quality and regulatory teams, and companies needing specific support for audits, remediation projects, QMS upgrades, or technical documentation improvement.
Are your course certificates accredited?
Our courses award a certificate of completion issued by ISO Cloud Consulting. We are a new company and the certificates are not yet accredited by an external body. We plan to apply for international recognition of our certificates before the end of 2027.
Do you only provide templates, or do you also provide consulting?
We do both. Some clients need structured tools, templates, and training materials. Others need hands-on consulting support to solve audit findings, fix broken systems, prepare for certification, or build compliant processes that work in practice.
Can you help if our QMS already exists but is not working properly?
Yes. A large part of our work is remediation. That includes weak CAPA systems, incomplete design controls, poor document control, ineffective internal audits, risk files that do not stand up in review, and quality systems that look compliant on paper but fail under audit or operational pressure.
Do you support companies remotely?
Yes. ISO Cloud Consulting is built to support companies remotely and efficiently. That means we can help with document review, system development, audit preparation, remediation planning, and ongoing advisory support without adding unnecessary complexity or delay.
How do we get started?
The best starting point is to contact us with your current stage, the main issue you need solved, and any timing pressures you are working under. From there, we can recommend the most sensible next step, whether that is a scoped consulting engagement, a focused remediation project, or the right course or toolkit.
Let’s Talk

Need practical medical device quality or regulatory support?

Whether you are building a QMS, preparing for ISO 13485 certification, fixing CAPA issues, strengthening your risk management file, or trying to get your documentation audit-ready, we can help you take the next step with clarity.

Share a few details about your business, your current stage, and the support you need. We will review your enquiry and come back with the most sensible next step.

ISO 13485 support Audit readiness CAPA and remediation Risk management

Request a Consultation

Tell us what you need help with. We reply by email within one business day and suggest a time for a free 30-minute scoping call.

Open the enquiry form Question about a template or download? Contact us

Or email isocloudconsulting@outlook.com