Offering consultancy services related to
Material Compliance & Medical Devices
About Me
Ilona Santavaara
With over 20 years of experience in regulatory affairs, material compliance, product safety, and sustainability, I specialize in helping companies of all sizes navigate complex legislative requirements with ease. Throughout my career, I have worked with a diverse range of products, including consumer electronics, wearable technology, medical devices and combination products.
Through, Pengin Oy, I offer tailored services in material compliance, as well as support with medical device regulatory affairs and quality management. My goal is to help businesses meet regulatory challenges with confidence and efficiency.
For a detailed look at my professional background, see my LinkedIn profile.
Areas of Expertise
Material Compliance
Restriction of hazardous substances in electrical and electronic equipment
Registration, evaluation, authorization, and restriction of chemicals in the EU market – containing the Annex XVII substance restrictions and list of REACH SVHC substances
Regulations on the safe use of chemicals in consumer products sold in California, containing the labelling requirement for user exposure
U.S. regulation on the management of chemicals used in manufacturing
Reporting requirements on per- and polyfluoroalkyl substances in various products
Compliance with the EU Medical Device Regulation regarding materials and substances.
Medical Devices
Implementation and maintenance of ISO 13485-compliant quality management systems to ensure product quality, regulatory compliance, and continuous improvement
Navigating the EU MDR to meet regulatory requirements, including technical documentation, risk management, clinical evaluation, and post-market surveillance
Development of medical device software according to IEC 62304 standards, covering the software lifecycle from design to maintenance
Application of IEC 62366 standards, including documentation, as well as planning and reporting of formative and summative usability evaluation and testing
Planning and conducting clinical evaluations in accordance with the latest MDCG guidance and MEDDEV 2.7.1 rev 4 to ensure medical devices are safe and effective for their intended use
Other Regulations
Requirements governing the management, recycling, and environmental impact of packaging materials.
Compliance with regulations on the use, disposal, and recycling of batteries, both in the EU and globally.
General guidance on compliance with various CE marking requirements for a range of product categories.
Requirements related to the recycling and disposal of electrical and electronic equipment
Product category specific rules on reducing the environmental footprint of products throughout their lifecycle, from design to disposal
Examples of Services
Material Compliance
Gap Analysis
Identifying requirements relevant for your product or business, gap analysis on your current material compliance documentation
Data Analysis
Analyzing data, such as full material declarations, test reports and statements of compliance to determine product compliance and possible gaps in your data
Reporting
Preparing a submission for ECHA SCIP database for your product, compiling answers for PFAS reporting or material compliance related customer requests
Processes
Building and helping put into action a process / way of working for your company to achieve material compliance
Examples of Services
Medical Devices
Gap Analysis
Gap analysis or assessment of your technical documentation
Internal Audits
Internal audits for your ISO 13485 quality management system. I am a ISO 13485 Lead Auditor (CQI and IRCA Certified Training Course)
Training
Training (live or online) on basics of MDR / ISO 13485, or on more advanced specialized topics
Processes
Helping you build a quality management system or individual processes
Contact
Get in touch via e-mail or LinkedIn to discuss more, and to see if I would be able to help your company with your specific situation.