One partner for every regulatory step your orthotic, prosthetic, foot health or rehabilitation product needs, from quality system to market authorisation and post-market surveillance, in more than 50 markets.
We work with manufacturers entering new markets, distributors who need to register the brands they carry, and investors who need to know a product is compliant before they commit. Our own team and trusted in-market specialists work to one plan, with Deliberate as your single point of contact.
Our regulatory focus
We specialise in four device families. Most are Class I or Class II medical devices, and many related products, such as comfort footwear and daily-living aids, are non-medical consumer products with their own conformity rules. We handle both, so you have one partner for the whole range.
- Orthotics: AFOs, KAFOs, spinal and upper-limb orthoses, cranial remoulding helmets, custom and prefabricated braces
- Prosthetics: components, sockets, liners, feet and knees
- Foot health: insoles, custom foot orthoses, diabetic and therapeutic footwear, foot scanning and pressure systems
- Rehabilitation equipment: mobility aids, wheelchairs, seating and positioning, therapy and assistive devices
Our regulatory services
Strategy and classification
- Device classification in every target market, for medical and non-medical products
- Regulatory pathway and market sequencing, so one technical file serves as many markets as possible
- Gap analysis of existing technical files and quality systems
- Regulatory due diligence for investors, acquisitions and distributors
Quality management systems
- ISO 13485 quality management systems, including MDSAP and the US FDA QMSR
- ISO 9001 quality and ISO 14001 environmental management systems
- Internal audits, CAPA, supplier controls and certification body audit support
Technical documentation
- Technical files and design history files
- Risk management to ISO 14971
- Clinical evaluation, biocompatibility and usability engineering
- Labelling, instructions for use and UDI
- Process validation, stability and shelf-life evidence
Registration and local representation
- Market authorisations and registrations, submissions and authority questions
- Authorised representative and local agent services, including EU Authorised Representative, UK Responsible Person, US Agent, SFDA Authorised Representative and Indian Authorised Agent
- Renewals, product changes and transfers between representatives
Import, distribution and product conformity
- Import, distribution and establishment licences
- SABER certificates and SASO technical regulations for Saudi Arabia
- CSA product testing, certification and inspection
- BIS certification in India and general product safety rules for non-medical products
- Customs clearance, logistics and supply-chain compliance
- Advertising and promotional approvals
Post-market
- Post-market surveillance plans and reports
- Vigilance, complaint handling and field safety corrective actions
- Keeping registrations current as regulations change
Manufacturing and localisation
- Feasibility studies and project reports for new production sites
- Product design and development support
- Process engineering and plant layout
- Local co-manufacturing partners and technology transfer, including Saudi and UAE localisation
Markets
Saudi Arabia
SFDA MDMA, Authorised Representative, MDNR, UDI, import and advertising licences, SABER and SASO.
UAE & GCC
Emirates Drug Establishment registration, plus Oman, Kuwait, Qatar and Bahrain.
European Union
EU MDR technical documentation, CE marking, EU Authorised Representative, EUDAMED, GPSR.
United Kingdom
MHRA registration, UK Responsible Person, UKCA and CE recognition.
United States & Canada
FDA registration and listing, 510(k), QMSR, US Agent, Health Canada licences, MDSAP.
India
CDSCO registration and licences, Indian Authorised Agent, BIS certification.
Africa
Egypt EDA, South Africa SAHPRA and national registrations across Africa.
Brazil & Latin America
ANVISA notification and registration, and Latin American markets.
Australia & Asia Pacific
TGA, ASEAN registrations and Central and South Asia.
How we work
- Assess: we review your product, classification and existing approvals
- Plan: we agree the markets, route, timeline and fixed budget
- Prepare and submit: we build or fix the documentation and manage every submission
- Maintain: we handle renewals, changes and post-market obligations
Delivered by Deliberate
- ISO 13485 quality management systems
- EU MDR technical documentation and certification: Germany
- SFDA MDMA, SASO and SABER: Saudi Arabia
- MoHAP registration: UAE
- CDSCO registration: India
The Deliberate AI platform
Our AI platform takes the repetitive work out of building technical files for ISO 13485, EU MDR and other certifications, so projects move faster and cost less.
Examples
Starband: SFDA MDMA for the full range of Class II cranial remoulding orthoses and post-surgical helmets within six months, starting from a weak technical file for each design.
ISO 13485, UK: took over a stalled project that had cost $300,000 over 12 months, and achieved certification within six months for $30,000.
Landis: SASO and SABER registration as non-medical equipment, supported by CSA equipment testing, for import into Saudi Arabia.
TurboMed Orthotics: ISO 13485 with TÜV Austria and SFDA MDMA for an external AFO, both within two months on a lean, fixed budget. See case studies →
