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Medical Device and Technology
“Concept to Commercialization”
Medical device manufacturers are under increasing pressure to deliver sophisticated products at affordable prices. Changing global regulatory norms and rising competition has forced companies to think beyond boundaries. For a successful product development strategy and for effective return on investment from discovery-to-product launch, medical device companies needs to align with right partner.
MakroCare with its multi-geographical presence along with a strong team of experts and medical device specialist can best assist you in global expansion of your products.
Our services include:
- Clinical Trials Management
- Site initiation
- Site management
- Feasibility studies
- Pivotal studies
- Clinical studies Data for Health Economics
- Regulatory Affairs
- Preparation of Device Master file / Technical Master File
- End to End support in 510(K), PMA, IDE, CE marking.
- Medical Device / IVD registration
- Liasioning with different Regulatory Authorities
- Query management
- Regulatory Compliance
- QMS Implementation
- Design SOP’s, Protocols & Report
- Third Party Audits
- Validation and Management of Quality Systems
- Post Marketing Vigilance
- Medical Device Reporting
- Case Processing
- Call Center (AE / Med Info / Product Complaints),
- 24/7 call center support for collecting reports on clinical trials and post-marketed products
- SAE management
- Signal detection & Risk-Benefit Analysis
- Literature search
- Global Expansion
- Feasibility assessment
- Acting as In- country Care Taker
- Preparation of Marketing Materials and collaterals
- Brand management
- Complete support in pre/ post launch activities
- KOL identification
- Distributor identification
- Sales force management
MakroCare is experienced in the following therapeutic areas:
- Cardiology
- Gastroenterology
- Orthopedic
- Ophthalmology
- Respiratory
- Spinal
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