Turn compliance
into confidence.
We help medical device manufacturers meet EU MDR 2017/745 and ISO 13485 requirements through clear, accurate and sustainable regulatory solutions.
Your regulatory solutions partner in healthcare.
TENA Consulting and Training Services provides time- and quality-focused support through an experienced specialist team while maintaining strict confidentiality. We interpret national and international regulations accurately and aim to be your solutions partner in the healthcare industry.
Our services include technical documentation for CE marking, quality management systems, global regulatory submissions, product registrations and tailored regulatory training.
A clear roadmap for your regulatory journey
Select a topic to review the scope of our support.
CE Marking
+
CE Marking
+Regulatory strategy, EU MDR gap assessment, technical documentation, change control, compliant labelling, risk management, clinical evaluation and post-market surveillance support.
Risk Management
+
Risk Management
+ISO 14971:2019 risk management throughout the device life cycle, including hazard identification, risk estimation, risk controls and residual-risk evaluation.
EUDAMED & UDI-DI
+
EUDAMED & UDI-DI
+Support for EUDAMED actor registration, SRN preparation, Basic UDI-DI structure and device UDI-DI data registration.
ÜTS Product Registration
+
ÜTS Product Registration
+Company and medical-device registration support within Türkiye’s Product Tracking System (ÜTS).
TSE Service Qualification
+
TSE Service Qualification
+Application and renewal support for the TSE Service Qualification Certificate required for relevant manufacturers, importers and technical service providers.
FDA Submissions
+
FDA Submissions
+US market-entry strategy, establishment registration and regulatory documentation support for applicable pathways, including 510(k) and PMA.
Global Registrations
+
Global Registrations
+Country-specific registrations and technical documentation for the United Kingdom, Switzerland, Latin America, the Middle East and Asia-Pacific markets.
Quality Management Systems
ISO 13485:2016
+
ISO 13485:2016
+QMS implementation, regulatory requirements, processes, procedures, work instructions, training and internal audits for certification readiness.
MDSAP
+
MDSAP
+Preparation of quality systems for the Medical Device Single Audit Program requirements of Australia, Brazil, Canada, Japan and the United States.
ISO 9001
+
ISO 9001
+Quality-system documentation, personnel training and internal audit support for ISO 9001 certification.
ISO 14971 Risk Analysis
+
ISO 14971 Risk Analysis
+Risk management planning, analysis, evaluation, control and reporting aligned with ISO 14971:2019.
Controlled, transparent and outcome-focused.
Each engagement is tailored to your products, team and target markets.
Needs and scope assessment
We clarify your current status, product portfolio and objectives.
Prioritised action plan
We turn requirements, responsibilities and deliverables into a practical plan.
Collaborative implementation
We prepare documentation while transferring knowledge to your team.
Review and sustainability
We prepare the system for audit and establish a structure for ongoing compliance.
Insights
Practical guidance on medical-device regulations and quality management systems.
Preparing Technical Documentation for CE Marking
The core sections of MDR technical documentation and key consistency checks for manufacturers.
Read article →Key Steps for EUDAMED and UDI-DI Registration
From actor registration to preparing a consistent device data set.
Read article →ISO 13485 Audit Readiness Checklist
The main QMS processes and records to review before an audit.
Read article →