Trusted by medical device companies worldwide
Regulatory services designed for real-world approvals
Regulatory Consulting
Find the right pathway and move your device toward approval in the markets that matter.
Quality Consulting
Build quality systems that support compliance and make daily operations easier to manage.
Verification & Validation
Generate the evidence needed to show your device is safe and performs as intended.
Additional Team Support
Add experienced specialists when your internal team needs more regulatory or quality capacity.
Design & Development
Develop medical device software with regulatory, quality, and risk requirements built in.
Business Setup & Corporate Services
Put the business structure in place to operate and grow in new markets.
01
Global Market Access
Want to enter a new market but unsure which regulatory route to follow? We help you understand the requirements, define the right market-entry strategy, and avoid decisions that could delay your launch.
Plan your market entry →
02
IVDR Consulting
IVDR requirements can expose gaps in classification, performance evidence, documentation, and post-market activities. We help turn those requirements into a practical path toward compliance.
Move your IVD toward compliance →
03
EU MDR Consulting
MDR compliance becomes difficult when technical documentation, clinical evidence, risk management, and QMS activities do not align. We help identify the gaps and build a clear route toward CE marking.
Prepare for EU MDR compliance →
04
FDA Consulting
Choosing the wrong FDA pathway or discovering submission gaps too late can cost valuable time. We help define your strategy, prepare the required evidence, and navigate the FDA process.
Build your FDA strategy →
05
Authorized Representative
Selling medical devices in markets where you are not established may require local representation. Get the regulatory support needed to meet your obligations and maintain access to the market.
Establish your local representation →
01
ISO 13485 Consulting
A QMS should help your company operate compliantly, not create unnecessary paperwork. We help build or improve an ISO 13485 system that supports your daily operations and certification goals.
Strengthen your QMS →
02
Audit & Inspection Readiness
Audits become stressful when gaps are discovered by the auditor instead of your team. We help identify weaknesses early and prepare your processes, people, and evidence before the audit begins.
Prepare for your next audit →
03
Quality & Risk Management Systems
Risks become harder and more expensive to manage when they are addressed too late. Build a practical system that connects risk management with your quality and product lifecycle activities.
Improve your risk management →
04
Regulatory Updates
Regulations continue changing after your device reaches the market. Stay informed about changes that affect your products and understand what actions your organization needs to take.
Stay ahead of regulatory changes →
01
Biocompatibility Testing
Choosing the wrong biological evaluation strategy can lead to unnecessary testing, higher costs, and delays. We help determine the evidence needed to demonstrate biological safety.
Plan your biocompatibility strategy →
02
Packaging & Labeling Compliance
Packaging and labeling problems can delay approval or create compliance issues after launch. Make sure your product information, symbols, labels, and packaging meet applicable requirements.
Review your packaging & labeling →
03
Electromagnetic Compatibility
EMC problems discovered late in development can lead to redesign and repeated testing. Prepare your device and test strategy before reaching the laboratory.
Prepare for EMC compliance →
04
Usability Testing
A device can meet technical specifications and still create risks when real users interact with it. Identify use-related risks and generate the evidence needed to support safe use.
Plan your usability activities →
05
Cybersecurity
Connected medical devices create risks that continue throughout the product lifecycle. Identify vulnerabilities, implement appropriate controls, and prepare the cybersecurity evidence regulators expect.
Strengthen device cybersecurity →
01
Additional Regulatory Team
Regulatory workloads can grow faster than your internal team. Add experienced specialists who support submissions, documentation, market access, and regulatory activities alongside your team.
Add regulatory capacity →
02
Additional Quality Team
Quality deadlines should not depend on whether your internal team has enough capacity. Add experienced support for QMS work, audits, CAPA, remediation, and quality projects.
Add quality capacity →
03
PRRC Services
EU MDR and IVDR require specific regulatory oversight responsibilities. Get qualified PRRC support without needing to recruit another permanent internal role.
Get PRRC support →
01
Company Registration
Expanding into another country can require more than regulatory approval for your product. Establish the legal business structure needed to begin operating in the market.
Set up your company →
02
Bank Account Opening
Setting up banking in a new market can slow down your business launch. Get practical support navigating the account-opening process and required documentation.
Open your business account →
“Easy Medical Device expertly prepared our MDR Technical File with professionalism and clear communication. They delivered on time without compromising quality. I highly recommend their services.”
Zoltan Dr. Balogh
EU MDR remediation project Q1-Q3 2023
Digital tools that make compliance simple
“Easy Medical Device expertly prepared our MDR Technical File with professionalism and clear communication. They delivered on time without compromising quality. I highly recommend their services.”
Karen Jaffe
EU MDR remediation project Q1-Q3 2023
