Your Trusted Partner in Global Regulatory Compliance
We deliver comprehensive, high-quality regulatory and compliance solutions tailored to medical device, IVD, and pharmaceutical companies worldwide. Leveraging extensive industry expertise, we help navigate complex regulatory requirements, streamline approval pathways, accelerate market access, and maintain ongoing compliance across international markets.
Overview
At Veritas Quality Solutions, we understand that regulatory compliance is not merely a legal obligation, it is a strategic imperative that determines your ability to bring life-changing medical devices to patients around the world. We provide comprehensive, high-calibre regulatory solutions tailored to medical device companies worldwide. Our team brings deep industry expertise to guide you through complex regulatory landscapes seamlessly, ensuring your products achieve rapid market entry and sustained compliance.
From early-stage product classification through rigorous clinical evaluation and global market authorizations, we empower Medical Device leaders to innovate with confidence.
Who We Serve
We partner with medical device organizations across the full spectrum of the industry:
Medical Device Manufacturers
From Class I self-certified devices to Class IIa, IIb, and Is products requiring Notified Body involvement, we support manufacturers at every stage of the regulatory lifecycle. Our expertise spans the full range of device technologies, including sterile devices, reusable surgical instruments, active devices, and software as a medical device (SaMD).
Startups and Emerging Companies
We help innovative startups navigate the regulatory pathway for the first time, providing practical guidance that balances regulatory rigor with commercial realities. From classification through to first market authorization, we are your partner at every step.
Established Manufacturers Expanding Globally
For manufacturers with existing approvals seeking to expand into new markets, we develop strategies that leverage your existing documentation and certifications to accelerate market entry.
Contract Manufacturers and Suppliers
We support contract manufacturers, component suppliers, and service providers who need to demonstrate compliance with customer requirements, regulatory standards, and industry codes of conduct.
Our Comprehensive Regulatory Solutions
Regulatory Strategy and Planning
Every successful regulatory journey begins with a clear strategy. We develop customized regulatory roadmaps that anticipate requirements, identify potential obstacles, and position your product for efficient approval in every target market.
What We Offer:
Device classification across multiple jurisdictions
Regulatory pathway determination (CE Mark, MDMA, ANVISA, NMPA, TGA, and others)
Market prioritization and sequencing strategies
Gap assessments against applicable regulatory requirements
Timeline development with key milestones and dependencies
Risk identification and mitigation planning
Quality Management Systems (QMS)
A robust quality management system is the foundation of regulatory compliance. We design, implement, and audit quality systems aligned with ISO 13485:2016, ISO 9001, and the FDA Quality Management System Regulation (QMSR), ensuring your organization is inspection-ready and certification-ready.
What We Offer:
QMS design and documentation development
Gap assessment against ISO 13485 and FDA QMSR requirements
Process implementation and training
Internal audit program development and execution
Pre-certification and mock audits
Supplier qualification and audit support
CAPA system development and effectiveness verification
Clinical Evaluation and Literature Reviews
Clinical evidence is central to demonstrating the safety, performance, and clinical benefit of medical devices. We prepare comprehensive Clinical Evaluation Reports (CERs) and conduct systematic literature reviews that follow rigorous regulatory guidelines, including MEDDEV 2.7/1 Rev. 4 and EU MDR Annex XIV.
What We Offer:
Clinical Evaluation Plan (CEP) development
Systematic literature review with PRISMA methodology
Critical appraisal using validated tools (RoB 2, NOS, QUADAS-2, AMSTAR 2)
Clinical Evaluation Report (CER) preparation
Equivalence assessment and justification
State of the Art (SOTA) analysis
Post-Market Clinical Follow-Up (PMCF) planning and integration
Global Regulatory Submissions
We manage the preparation, submission, and maintenance of regulatory dossiers in markets around the world. Our team understands the specific format, content, and procedural requirements of each regulatory authority.
What We Offer:
European Union: CE Mark technical documentation, MDR conformity assessment support, EUDAMED registration
Saudi Arabia: Medical Device Marketing Authorization (MDMA) through SFDA
Brazil: ANVISA registration and notification
United Kingdom: UKCA marking, MHRA registration
China: NMPA filing and registration
Australia: ARTG inclusion through TGA
New Zealand: WAND notification through Medsafe
Indonesia: BPOM registration through Regalkes
Malaysia: MDA registration through MeDC@St
Thailand: Thai FDA registration
Turkey: TITCK registration through ÜTS
Russia and EAEU: National and unified registration
Azerbaijan: State registration
And other international markets as required
cGMP and Green Listing Support
Current Good Manufacturing Practice (cGMP) compliance is essential for medical device manufacturers. We support clients in achieving and maintaining cGMP compliance, including support for green listing the process by which manufacturers demonstrate GMP compliance to regulatory authorities and customers.
What We Offer:
cGMP gap assessments and remediation
Facility and process validation support
Documentation and record-keeping systems
Training on cGMP requirements
Green listing application support
Regulatory inspection readiness
Authorized Representative Services
Many markets require a local authorized representative to act on behalf of foreign manufacturers. We provide access to a panel of qualified representatives across key jurisdictions.
What We Offer:
European Authorized Representative (EC REP), For EU market access under MDR
Swiss Authorized Representative (CH REP), For Swiss market access
UK Responsible Person (UK REP), For UK market access under UK MDR
US Agent, For FDA communications and regulatory obligations
Saudi Authorized Representative, For SFDA registration and compliance
Other market-specific representatives, As required by local regulations
On-Site Audits and Compliance Verification
We conduct professional on-site audits on behalf of clients across Pakistan, KSA, UAE, and Turkey, verifying regulatory readiness and compliance with ISO 9001, ISO 13485, and MDR requirements.
What We Offer:
Pre-certification audit readiness assessments
ISO 9001 and ISO 13485 compliance verification
MDR compliance verification
Unannounced audit readiness
Supplier and subcontractor audits
Customer audit support
Customer Code of Conduct Compliance
Major customers across the healthcare sector require suppliers to demonstrate compliance with customer-specific codes of conduct and sustainability frameworks. We provide advisory services to help you align with these requirements.
What We Offer:
EcoVadis assessment preparation and support
Bunzl Supplier Code of Conduct compliance
Other customer-specific code of conduct alignment
Policy development and evidence collection
Sustainability metrics tracking and reporting
Post-Market Surveillance and Vigilance
Regulatory compliance continues after market authorization. We help you establish and maintain effective post-market surveillance systems that satisfy regulatory requirements and support ongoing compliance.
What We Offer:
Post-Market Surveillance (PMS) plan development
Periodic Safety Update Report (PSUR) preparation
Vigilance and incident reporting procedures
Field Safety Corrective Action (FSCA) support
Trend analysis and signal detection
CER update management
Our Global Reach
We have successfully supported device registrations and market access in:
Why Choose Veritas Quality Solutions
Deep Industry Expertise
Our team has vast experience across the full spectrum of medical device regulations, from the legacy Medical Device Directive (MDD) to the current Medical Device Regulation (MDR), covering Class I, Class Ir, Class Is, Class IIa, and Class IIb products. We understand the nuances of each regulatory framework and how to navigate them efficiently.
Pioneering Track Record
We are pioneers in Pakistan for MDR certifications, having successfully guided companies to Class IIa, IIb, and Is certifications with SGS Belgium. Our team was the first in the country to achieve these milestones, establishing our reputation as a trusted leader in regulatory consulting.
Global Network
We maintain relationships with Notified Bodies, authorized representatives, testing laboratories, and regulatory consultants around the world. This network gives you access to the expertise and resources you need, wherever your products are destined.
End-to-End Support
From early-stage product classification through rigorous clinical evaluation and global market authorizations, we support you at every phase of the regulatory lifecycle. Whether you need strategic advice, hands-on documentation support, or representation before regulatory authorities, we are by your side.
Practical, Client-Focused Approach
We do not provide generic advice. Every solution we deliver is tailored to your products, your objectives, and your constraints. We work as an extension of your team, providing practical, actionable support that moves your business forward.
Commitment to Excellence
We hold ourselves to the highest standards of quality and integrity in everything we do. Our work is accurate, defensible, and aligned with the rigorous expectations of regulatory authorities and Notified Bodies worldwide.
Our Mission
To empower Medical Device leaders to innovate with confidence by providing comprehensive, high-calibre regulatory solutions that ensure rapid market entry and sustained compliance.
We believe that regulatory compliance should be an enabler of innovation, not a barrier. By navigating complex regulatory landscapes seamlessly on your behalf, we free you to focus on what you do best developing the medical devices that improve and save lives.
Get Started
Whether you are a startup preparing for your first regulatory submission, an established manufacturer expanding into new markets, or a medical device company seeking regulatory support, Veritas Quality Solutions is ready to help.
Contact us today to discuss how we can support your regulatory objectives.